ASCO 2021 Liver Cancer Update
The liver cancer trials presented at American Society of Clinical Oncology (ASCO) 2021 were mainly focused on first-line treatments, with a few trials in the neoadjuvant, adjuvant and second-line setting.
What is new in Oncology? Learn everything about the latest advancements in oncology on the MediPR (MediPaper) website. We have the latest news for different oncologic diseases, including immunotherapy, endocrine therapy, targeted therapy, and chemotherapy.
Advancing care for advanced renal cell carcinoma: choosing the optimal therapy for you patients
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The evolving role of NK1 in CINV management
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Lung Cancer Update April 2021
With the World Conference on Lung Cancer (WCLC) 2020 completed last January, several new and clinical relevant phase 2 and phase 3 studies on Lung Cancer have been published. We summarised some key data for you.
Abemaciclib: A review of the evidence through clinical cases
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The Role of Patient Blood Management for Inflammatory Bowel Disease
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Breast cancer update January 2021
With the San Antonio Breast Cancer Conference (SABCS) 2020 by AACR just completed, several new and clinical relevant phase 2 and phase 3 have been published in the Journal of the American Medical Association, Clinical Cancer Research, New England Journal of Medicine, Journal of Clinical Oncology, and Lancet Oncology. [‘mediPr] provides you with an overview.
Osimertinib approved as the first adjuvant treatment for early non-small cell lung cancer
Lung cancer is a leading cause of cancer-related death. In East Asian non-small cell lung cancer (NSCLC) patients, epidermal growth factor receptor (EGFR) mutations occur in 40-55% of lung adenocarcinomas.
Increasing dose frequency of lanreotide autogel injections in neuroendocrine tumours
Somatostatin analogues (SSA) control the hormonal hypersecretion in pancreatic and midgut neuroendocrine tumours (NETs), with antiproliferative, antiangiogenic and proapoptotic effects. Lanreotide autogel is a long-acting SSA that is considered the therapy of choice along with octreotide, in controlling symptoms associated with gastroenteropancreatic (GEP)-NETs.
Cabotegravir and rilpivirine intramuscular combination safe in women
Women account for a disproportionate percentage of new human immunodeficiency virus (HIV) infections in sub-Saharan Africa, comprising 59% of 18 million new adult HIV infections in 2017.
HCV-infected kidneys safe for transplantation with antiviral treatment
Kidney transplants are the best treatment for end-stage renal disease (ESRD), with better survival outcomes than haemodialysis or peritoneal dialysis. However, in Hong Kong as well as much of the rest of the world, there is an increasing gap between the number of patients requiring a transplant and the number of organs available.
Baloxavir marboxil recommended as post-exposure prophylaxis to influenza by EMA
Seasonal influenza is common between January to March, and July to August in Hong Kong. Baloxavir marboxil is the first influenza antiviral with a novel mechanism of action to be approved in almost two decades, and was registered for use in Hong Kong in February 2019.
US FDA approved immune-checkpoint inhibitors updated 08-Dec-2020
Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.
Detecting metastases with PSMA-PET in prostate cancer
Conventional imaging with computed tomography (CT), magnetic resonance imaging (MRI) and bone scans, are the current standard of care for imaging prostate cancer. Accurate imaging primarily relies on nodal metastases size for detection.
ASCO Guidelines for the Use of Systemic Therapies in Advanced Hepatocellular Cancer
Hepatocellular carcinoma (HCC) accounts for 80% of all liver cancers, and 55% of all HCC cases worldwide are reported from China. In Hong Kong, liver cancer is the fourth most common cancer and the third most common cause of cancer death.
Sotorasib for the treatment of KRASG12C mutated lung cancer
RAS is the most frequently mutated gene family in cancers, with KRAS mutations being involved as a driver in three of the most lethal cancers – lung cancer, colorectal cancer, and pancreatic cancer. Incidence of KRAS mutations vary between ethnicity with Caucasians having a higher incidence than African-Americans or Asians. In non-small lung cancer (NSCLC), the most common KRAS mutation is G12C. In Asia, G12C mutations in particular account for 14.5% of KRAS mutations in the Chinese population. KRAS G12C was identified in 4.3% of lung cancer samples and 2.5% of colorectal cancer samples.
Capmatinib therapy for the treatment of MET-positive non-small cell lung cancer
A number of tyrosine kinase inhibitors (TKIs) are now available for the treatment of various types of non-small cell lung cancers (NSCLC), including epidermal growth factor receptor (EGFR)-mutated and anaplastic lymphoma kinase (ALK)-rearranged NSCLC. However, amplification of the MET gene, which codes for the hepatocyte growth factor receptor (HGFR), has been found to be one of the most prominent mechanisms of secondary resistance to EGFR TKIs. Similarly, the MET exon 14 (METex14) mutation has also emerged as a potential tumour driver due to its role in cancer proliferation, and thus also a promising target for NSCLC.
Selpercatinib displays efficacy in RET fusion-positive non-small cell lung cancer
Aberrant RET activation has shown to be a clinical driver of tumour growth and proliferation. It is reported that 1-2% of non-small cell lung cancer patients have activating RET fusions. Clinical characteristics of these patients are generally younger (<60 years) with minimal or no smoking history, and frequent presentation with brain metastases at diagnosis of advanced disease. RET mutations are mutually exclusive with other common lung cancer genetic abberations, such as reported for KRAS, EGFR, and ALK.
First liquid biopsy for NSCLC to receive FDA approval
The development of new targeted therapies for non-small cell lung cancer (NSCLC) in recent years has changed the standard of care for the later stages of NSCLC in specific population groups.
ESMO releases the first guideline on NGS testing in cancers
Precision therapies were first approved for cancer in 1998, when trastuzumab was approved for HER2+ breast cancer, opening the door for other targeted therapies such as imatinib for Philadelphia chromosome-positive chronic myelogenous leukaemia.
Residual risk of hepatocellular carcinoma in older Hepatitis C patients even after viral clearance
Infection with the hepatitis C virus (HCV) can lead to chronic hepatitis C infection (CHC) and liver complications such as fibrosis, hepatocellular carcinoma (HCC), cirrhosis, and end-stage liver disease.
Updated human papillomavirus vaccination and testing recommendations from the American Cancer Society
Human papillomavirus (HPV) is one of the most common causes of sexually transmitted disease worldwide. HPV is associated with a variety of clinical conditions that can range from cutaneous warts to cervical or anal cancer. Cervical cancer is the third most common cancer in women in the United States, and may constitute up to 25% of all female cancers in developing countries.
Lower-risk MDS patients benefit from novel drug, imetelstat
Myelodysplastic syndromes (MDS) are a heterogenous group of clonal haematopoietic disorders that carry a risk of progression to acute myeloid leukaemia (AML). Patients are stratified into risk groups due to the heterogeneity of the disease, which is also exemplified by median overall survival (OS) of 8.8 years for very low risk, and 0.8 years for very high risk patients. Due to symptoms such as anaemia, supportive red blood cell (RBC) transfusions are needed in 80-90% of patients during their disease course, although RBC dependence has been shown to be an adverse prognostic marker.
Carboplatin plus paclitaxel to be the new standard of care for anal cancer
The incidence of anal cancer has been increasing over the past decade, but currently still constitutes 0.5% of all cancer diagnoses in the United States. When the cancer has metastasised, prognosis remains poor, with relative 5-year survival rates of approximately 30%. The current standard of care for metastatic anal cancer is cisplatin-based chemotherapy combined with 5-fluorouracil (5-FU). However, no randomised clinical trial investigating the optimal chemotherapy regimen for this disease has been conducted. The InterAAct trial was launched to investigate cisplatin plus FU against carboplatin plus paclitaxel in advanced anal cancers, and full results were recently published in the Journal of Clinical Oncology.
ASCO 2020 Lung, Breast, and Liver Cancer Update
This year, ASCO 2020 was held as a virtual conference due to the COVID-19 pandemic. This is a summary of key trials presented at ASCO, focusing primarily on breast cancer, liver cancer, and lung cancer.
Second-line treatment of gastric cancer or cancer of the gastroesophegeal junction: a case study of ramucirumab in Hong Kong
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Capivasertib added to fulvestrant improves progression-free survival in advanced breast cancer patients
Adding capivasertib to fulvestrant improves the progression-free survival (PFS) in postmenopausal women with oestrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer resistant to aromatase inhibitors, concluded Jones et al. (2020) in Lancet Oncology.
Capivasertib plus paclitaxel improves survival of metastatic triple-negative breast cancer patients
Adding capivasertib to paclitaxel improved the progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (TNBC) who had not received prior treatment for metastatic disease. Predominantly patients with PIK3CA/AKT1/PTEN-altered tumours had a more pronounced PFS and overall survival (OS) benefit, as reported by Schmid et al. in the Journal of Clinical Oncology
Ribociclib plus Fulvestrant Improves Survival in Advanced Breast Cancer
In patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, adding ribociclib to fulvestrant improved the overall survival (OS) by 28% compared to fulvestrant alone, as reported by Slamon et al. (2019) in The New England Journal of Medicine.
ASCO 2019 Lung Cancer: 36 Oral Presentations of the ASCO19 lung cancer track summarised
Non-small cell lung cancer (NSCLC) was a key feature of the American Society of Clinical Oncology (ASCO) 2019 annual meeting. This year, exciting results with neoadjuvant immunotherapy (I-O) from the LCMC3, NEOSTAR, and GECP16/03_NADIM studies as well as combinations of I-O Â and PARP-inhibitors with chemoradiation therapy, and more. A summary of 36 oral presentations on NSCLC, SCLC, and Mesothelioma.
ASCO 2019 Breast Cancer: The ASCO19 breast cancer track summarised
Breast cancer: a front-runner when it comes to the development of novel therapeutic strategies. With the advent of newer targeted- and immunotherapies, oncologists have an increment of options to offer their patients. The American Society of Clinical Oncology’s (ASCO) 2019 Breast Cancer track offered an extensive look at the latest advancements and updates from on-going trials covering the various subtypes of breast cancer.
Venetoclax FDA approved for CLL and SLL
On 15 May 2019, the FDA approved venetoclax (Venclexta®, AbbVie/Genentech) for the treatment of adult chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) patients.
FDA approves avelumab plus axitinib for renal cell carcinoma
On 14 May 2019, the FDA approved the combination of avelumab (Bavencio®, Merck KGaA/Pfizer) plus axitinib (Inlyta®, Pfizer) for the first-line treatment of advanced renal cell carcinoma (RCC) patients.
Ramucirumab FDA approved for hepatocellular carcinoma
On 10 May 2019, the FDA approved single agent ramucirumab (Cyramza®, Eli Lilly) for the treatment of hepatocellular carcinoma (HCC) patients previously treated with sorafenib and who have an alpha-fetoproteintein (AFP) of ≥ 400 ng/mL.
T-DM1 FDA approved for early breast cancer
On the 3rd of May 2019, the FDA approved ado-trastuzumab emtansine (Kadcyla® [T-DM1], Genentech/Roche) as adjuvant therapy for human epidermal growth factor receptor (HER2)-positive early breast cancer (EBC) patients with residual invasive disease after neoadjuvant treatment with a taxane and trastuzumab.
Ivosidenib FDA-approved as first-line treatment for AML patients with IDH1 mutation
On the 2nd of May 2 2019, the FDA approved ivosidenib (Tibsovo®, Agios) as treatment for newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old and AML patients with comorbidities precluding intensive induction chemotherapy. Patients should harbour a susceptible IDH1 mutation, as per the FDA-approved Abbott RealTime™ IDH1 Assay, to be legible for ivosidenib treatment.
Can a novel, temporary, and fully resorbable surgical implant improve the outcome of common hockey and soccer injuries?
UPPSALA, Sweden, April 24, 2019 /PRNewswire/ — Researchers of the Erasmus University Medical Center in Rotterdam − the Netherlands, consider that the synthetic and fully resorbable TIGR® Matrix surgical mesh (Novus Scientific AB, Uppsala − Sweden) may reduce frequent risks related to the surgical repair of Sportsman’s hernia.
Pembrolizumab plus axitinib FDA approved for the first-line treatment of advanced renal cell carcinoma patients
On 19 April 2019, the FDA approved the programmed death 1 (PD-1) inhibitor pembrolizumab (KEYTRUDA®, Merck) plus axitinib – a selective and potent receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 – as a first-line treatment for advanced renal cell carcinoma (RCC) patients.
KEYNOTE-158: pembrolizumab in previously treated advanced cervical cancer
Immunotherapy with programmed death 1 (PD-1) antibody pembrolizumab led to an objective response rate (ORR) of 14.6% in previously treated advanced cervical cancer patients with PD-L1–positive disease, as reported by Chung et al. on behalf of the KEYNOTE-158 investigators in the Journal of Clinical Oncology.
Atezolizumab +/- cobimetinib vs regorafenib for previously treated metastatic colorectal cancer (IMblaze370)
Combining programmed death 1 ligand (PD-L1) inhibitor atezolizumab with MEK-inhibitor cobimetinib in patients with previously treated metastatic colorectal cancer (mCRC) does not improve the overall survival (OS) when compared to regorafenib, as was reported by the investigators of the IMblaze370 (NCT02788279) trial in the Lancet Oncology.
Palbociclib approved for the treatment of male breast cancerÂ
On 4 April 2019, the US FDA approved palbociclib (Ibrance®, Pfizer) plus aromatase inhibitor or fulvestrant for the treatment of male patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Erdafitinib FDA approved for the treatment of metastatic urothelial carcinoma
On 12 April 2019, the FDA granted accelerated approval to erdafitinib (Balversa®, Janssen) for the treatment of locally advanced or metastatic urothelial cell carcinoma (mUCC) progressed during or following a platinum-containing regimen, including progression within 12 months of (neo)adjuvant platinum-based chemotherapy, and whose tumours harbour susceptible fibroblast growth factor receptor (FGFR) 3 or FGFR2 genetic alterations as determined by the FDA approved companion diagnostic (CDx), the therascreen® FGFR RGQ RT-PCR Kit by Qiagen.
Atezolizumab FDA approved for extensive-stage small cell lung cancer (SCLC)
On 18 March 2019, the FDA approved atezolizumab (Tecentriq®, Genentech) plus carboplatin and etoposide as front-line treatment of adult extensive-stage small cell lung cancer (ES-SCLC) patients.
Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer
On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).
Combinations: upcoming treatment strategies in metastatic renal cell carcinoma
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Trifluridine/tipiracil combination FDA approved for metastatic gastric or GEJ adenocarcinoma
On 22 February 2019, the FDA approved the fixed combination tablets of the nucleoside metabolic inhibitor trifluridine plus the thymidine phosphorylase inhibitor tipiracil (Lonsurf®, Taiho Pharmaceutical) for the treatment of adult metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients pretreated with two or more prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan plus (when appropriate) HER2/neu-targeted therapy.
Pembrolizumab FDA approved for adjuvant treatment of melanoma
On 15 February 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of melanoma patients with lymph node involvement following complete resection.
Trastuzumab-biosimilar Ontruzant® FDA approved in several indications
On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.
Cabozantinib FDA approved in HCC patients failing sorafenib
On 14 January 2019, the FDA approved cabozantinib (Cabometyx®, Exelixis) for hepatocellular carcinoma (HCC) patients previously treated with sorafenib.
Erasmus University MC investigating a new surgical matrix to reduce post-operative complications
The synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala − Sweden) might be an interesting candidate for the prevention of complications frequently observed with permanent mesh placement, according to Professor Johan Lange of the Erasmus University in Rotterdam − the Netherlands.
Keytruda® FDA approved for recurrent and metastatic Merkel cell carcinoma
On 19 December 2018, pembrolizumab (Keytruda®, Merck) received accelerated approval by the FDA for the treatment of recurrent locally advanced or metastatic (R/M) Merkel cell carcinoma (MCC) in adult and paediatric patients.
Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients
On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).
Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)
On 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer
On 19 December 2018, the FDA approved olaparib (Lynparza®, AstraZeneca) as a maintenance treatment for adult advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients who achieving a complete or partial response to first-line platinum-based chemotherapy and who have deleterious germline or somatic BRCA-mutatations (gBRCAm or sBRCAm) by an FDA-aproved test or who are suspected to have deleterious BRCA-mutatations (BRCAm).Â
Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer
On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.
Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC
On 6 December 2018, the FDA approved atezolizumab (Tecentriq®, Roche/Genentech) plus bevacizumab and chemotherapy with paclitaxel and carboplatin for the frontline treatment of metastatic non-squamous non-small cell lung cancer (NSq NSCLC) patients not harbouring any EGFR or ALK genomic tumour aberrations.
MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab
On the first day of the 2018 American Society of Hematology (ASH) Annual Meeting, an additional year of follow-up data from the practice-changing MURANO study were presented to the audience by Professor John F. Seymour. In the trial’s setting of relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL), the non-chemo-containing regimen venetoclax (Venclexta®, AbbVie/Roche) plus rituximab was associated with maintained superior progression-free survival (PFS) and overall survival (OS) over standard-of-care chemoimmunotherapy with bendamustine plus rituximab. At the same time, a durable post-treatment disease control is also attainable with the fixed-duration chemo-free regimen.
TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy
Onlay mesh placement of the synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala — Sweden) for the prevention of incisional hernia in septic patients undergoing emergency laparoscopy showed encouraging efficacy and safety in a small retrospective study, as presented during the XXVIII Waterford Surgical October Club Meeting.
Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations
On 28 November 2018, the FDA approved gilteritinib (Xospata® [ASP2215], Astellas) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML) harbouring FLT3 mutations as confirmed by an FDA-approved companion diagnostic test (CDx).
TKR inhibitor larotrectinib (Vitrakvi®) FDA approved for cancers with NTRK gene fusion
On 26 November 2018, the FDA granted accelerated approval to the first-in-class tropomyosin receptor-kinase (TRK) inhibitor larotrectinib (Vitrakvi®, Loxo Oncology/Bayer) for the treatment of adult and paediatric patients with solid tumours that are metastatic or not amenable to surgery, harbour the neurotrophic receptor tyrosine kinase (NTRK) gene fusion in the absence of known acquired resistance mutations, and whose cancer progressed following treatment or for whom are no satisfactory other treatment options available.
Venetoclax plus azacitidine, decitabine, or low-dose cytarabine FDA approved in elderly AML patients
On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in patients with comorbidities precluding intensive induction chemotherapy.
Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients
On 21 November 2018, the FDA approved glasdegib (Daurismo®, Pfizer) in combination with low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in patients of 75 years or older and in patients with comorbidities contraindicating intensive induction chemotherapy.
The Emerging Role of Yttrium-90 in Primary and Metastatic Liver Cancer
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Emapalumab FDA approved in adult and paediatric patients with primary hemophagocytic lymphohistiocytosis
On 20 November 2018, the FDA approved the interferon-γ neutralising monoclonal antibody emapalumab (Gamifant®, Novimmune) for the treatment of adult and paediatric (newborn and older) patients with refractory, recurrent, or progressive primary haemophagocytic lymphohistiocytosis (HLH) or in patients intolerant to conventional HLH therapy.
Brentuximab vedotin (Adcetris®) plus chemotherapy approved for several CD30 expressing lymphomas
On 16 November, 2018, the FDA approved brentuximab vedotin (Adcetris®, Seattle Genetics) in combination with chemotherapy for the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS).
Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction
UPPSALA, Sweden, Nov. 21, 2018 /PRNewswire/ — Using the synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala — Sweden) improves the outcome in breast cancer patients undergoing immediate reconstruction, as published in the Journal of Plastic Surgery and Hand Surgery.
Pembrolizumab FDA approved in hepatocellular carcinoma patients pretreated with sorafenib
On 9 November 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.
Lorlatinib FDA approved for metastatic ALK-positive NSCLC
On November 2nd 2018, lorlatinib (LORBRENA®, Pfizer) received accelerated approval by the FDA for the second- and third-line treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC). Third-line patients should have had progression on crizotinib and another ALK-inhibitor for metastatic disease, and second-line patients should have had progression on either alectinib or ceritinib in the first-line for metastatic disease.
ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised
Whereas this year’s American Society of Clinical Oncology Annual Meeting (ASCO 2018) boasted two Phase III studies and four Phase II studies with notable results in hepatocellular carcinoma (HCC), the trend did not continue to the European Society for Medical Oncology Conference (ESMO 2018), held in Münich, Germany between October 19-23, 2018. The focus for this years ESMO was mostly on biliary-tract cancers (BTC). Welcome to the hepatobiliary track of ESMO 2018.
Pembrolizumab plus chemotherapy approved for metastatic squamous NSCLC
On October 30th 2018, the FDA approved the use of programmed death 1 (PD-1) inhibitor pembrolizumab (Keytruda®, Merck) in combination with carboplatin plus paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).
Management of Immune-Mediated Hepatitis: a Case Report
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PARPi talazoparib FDA approved for deleterious gBRCAm HER2‑negative breast cancer
On October 16, 2018, the FDA approved PARP-inhibitor talazoparib (Talzenna®, Pfizer) for use in patients with deleterious or suspected deleterious germline BRCA-mutated locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Patients should be selected for the PARP inhibitor (PARPi)-treatment using an FDA-approved companion diagnostic (CDx) for talazoparib.
Anti-PD1 sintilimab plus biosimilar bevacizumab receive IND-status by China NMPA
SUZHOU, China, Oct. 14, 2018 /PRNewswire/ — The combination therapy of novel programmed death 1 (PD-1) antibody IBI308 (sintilimab, Innovent Biologics) with biosimilar bevacizumab antibody IBI305 (Innovent Biologics) has received the investigational new drug (IND) application for clinical development approval by the National Medical Products Administration (NMPA, formerly known as CFDA) in China.
IMpower133: first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer
Atezolizumab (Tecentriq®, Roche/Genentech) plus standard chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer (SCLC) was associated with a significantly longer overall survival (OS) and progression-free survival (PFS) when compared with chemotherapy alone.
Pembrolizumab plus chemotherapy effective in squamous NSCLC
Pembrolizumab (Keytruda®, Merck) in combination with chemotherapy was associated with longer overall survival (OS) and progression-free survival (PFS) when compared to placebo plus chemotherapy in patients with untreated metastatic squamous cell non-small cell lung cancer (NSCLC).
Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer
Adding ipilimumab (IPI [Yervoy®, Bristol-Myers Squibb]) to nivolumab (NIVO [Opdivo®, Bristol-Myers Squibb]) induction followed by maintenance with single-agent NIVO had a superior objective tumour response rate and progression-free survival (PFS) when compared to NIVO alone in patients with persistent or recurrent epithelial ovarian cancer.
Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC
Brigatinib (Alunbrig®, Ariad) significantly prolongs the progression-free survival (PFS) in anaplastic lymphoma kinase (ALK) inhibitor-naïve patients with ALK-rearranged non-small cell lung cancer (NSCLC) when compared to crizotinib, as resulted from the ALTA-1L study.
CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW
TOKYO and BASKING RIDGE, N.J., October 3, 2018 /PRNewswire/ — The Japan Ministry of Health, Labour and Welfare (MHLW) granted the Orphan Drug designation to axicabtagene ciloleucel (KTE-C19, Daiichi Sankyo) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL),  high-grade B-cell lymphoma (HGBL), and transformed follicular lymphoma (TFL), which are all aggressive forms of non-Hodgkin lymphoma (NHL).Â
PD-1 mAB cemiplimab FDA approved for locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC)
On September 28, 2018, the FDA approved programmed death 1 (PD-1) immune-checkpoint inhibitor cemiplimab-rwlc (Libtayo®, Regeneron) for use in patients with metastatic cutaneous squamous cell carcinoma (CSCC) and patients with locally advanced CSCC unamenable for curative surgery or curative radiation.
JAVELIN Lung 200: avelumab vs docetaxel for pretreated NSCLC
Avelumab (Bavencio®, Merck KGaA) does not improve the overall survival (OS) in non-small cell lung cancer (NSCLC) patients previously treated with platinum-doublet chemotherapy, as resulted from the JAVELIN Lung 200 study (NCT02395172). The safety profile favoured avelumab over docetaxel.
Dacomitinib FDA approved for the first-line treatment of metastatic EGFR-mutated NSCLC
On September 27, 2018, the FDA approved dacomitinib (Vizimpro®, Pfizer) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R mutations as confirmed by an FDA-approved test.
©United States Food and Drug Agency US FDADuvelisib FDA approved for adult patients with R/R CLL or SLL
On September 24, 2018, the US FDA granted regular approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior therapies.
Duvelisib FDA approved for adult patients with R/R follicular lymphoma
On September 24, 2018, the US FDA granted accelerated approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies.
Frontline atezolizumab plus chemotherapy improves PFS in NSCLC
An interim analysis of the Phase III IMpower132 study showed that atezolizumab (Tecentriq®, Roche/Genentech) plus platinum-based chemotherapy (cisplatin or carboplatin) with pemetrexed improves the median progression-free survival (PFS) in treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). The median PFS for atezolizumab plus pemetrexed and a platinum salt was 7.6 months vs 5.2 months with chemotherapy alone (HR=0.60, 95% CI: 0.49-0.72; p<0.0001).
First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC
First-line osimertinib was associated with a clinically meaningful progression-free survival (PFS) improvement when compared to a standard-of-care (SOC) epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in a sub-analysis of Asian patients who participated in the FLAURA trial (NCT02296125).
Early breast cancer treatment in China remains conservative
Breast-conserving surgery is uncommon in China, and despite routinely performing SLNB the uptake of the ACOSOG Z0011 study recommendation to treat selected sentinel node-positive patients with whole breast irradiation and adjuvant systemic therapy instead of ALND remains low at only 17% of Chinese centres. These were the key findings of a national survey among 520 Chinese hospitals.
©MediPaper Medical Communications LtdImmunoOncology: Dr Oscar Chan on the treatment of irAE rash
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Prof Stefan Kasper on I-O in EXTREME-ineligible SCCHN
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Camrelizumab anti-PD-1 with or without chemotherapy for NPC
Camrelizumab (SHR-1210, Hengrui Medicine), a novel programmed death 1 (PD-1) inhibitor, plus gemcitabine and cisplatin showed a manageable toxicity profile with promising, preliminary anti-tumour activity in treatment-naïve Chinese nasopharyngeal carcinoma (NPC) patients. Larger, randomised controlled trials may provide further insight into the role of anti-PD1 for NPC, wrote the authors in the Lancet Oncology.
Moxetumomab pasudotox-tdfk FDA approved for hairy cell leukaemia
On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti®, AstraZeneca) for adult patients with relapsed or refractory (R/R) hairy cell leukaemia (HCL) who had received at minimum two prior systemic therapies, of which one a purine nucleoside analogue (PNA).
©MediPaper Medical Communications LtdI-O in Special Populations: the Treatment of Immunotherapy-Induced Pneumonitis
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Venetoclax FDA label updated to include Minimal Residual Disease negativity data
On the 11th of September 2018, the FDA updated the label of venetoclax tablets (VENCLEXTA®, Abbvie) in combination with rituximab (MabThera®, Roche) to include information about pre-treated patients with chronic lymphocytic leukemia (CLL) in the Phase III MURANO trial who had achieved Minimal Residual Disease (MRD)-negativity.
Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan
TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018 — The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.
© Eraxion / 123RF Stock PhotoCapmatinib plus gefitinib promising in MET-dysregulated NSCLC
The combination capmatinib (INC280, Novartis) plus gefitinib (Iressa®, AstraZeneca) showed promising, early phase efficacy in patients with mesenchymal-epithelial transition factor (MET)-dysregulated and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
© Royaltystockphoto / 123RF Stock PhotoCAR-TCR Summit 2018: Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer
CARsgen Therapeutics, a Shanghai-based clinical-stage immune-oncology company committed to developing Chimeric Antigen Receptor T (CAR-T) cell therapies for cancer, presented preliminary data of their first-in-class CAR-Claudin18.2 T-cell clinical trial in pancreatic and gastric cancer patients during the 2018 CAR-TCR Summit in Boston.
© Kentoh / 123RF Stock PhotoDRIVER connects cancer patients in China and the United States to the best care
SAN FRANCISCO and SHANGHAI, Sept. 6, 2018/PRNewswire/ — Today, Driver, a global technology platform that connects cancer patients to the best treatments, launches in the United States and China. Driver’s platform enables any patient, anywhere in the world, to access treatment options across an unprecedented network of cancer centres without leaving home.
Plasma TMB predicts response to atezolizumab in NSCLC patients
A high tumour mutational burden in the plasma (bTMB) is a clinically actionable biomarker for atezolizumab (Tencentriq®, Roche) treatment in patients who failed 1st-line platinum-based therapy for advanced non-small cell lung cancer (NSCLC).
© luchschen / 123RF Stock PhotoFirst-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation
Biosceptre has announced the initiation of its Phase 1 clinical study with the peptide vaccine BIL06v. BIL06v is a peptide-protein conjugate that recruits the patient’s immune system to make antibodies specifically targeted at nfP2X7-expressing cancer cells resulting in tumour cell death.