Dosing issues with DOACs in Asian real world setting
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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.
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Lung cancer is one of the leading cancers in Hong Kong, accounting for 26.4% of cancer mortality in 2018. Approximately 80% of the lung cancers are non-small cell lung cancer (NSCLC).
Non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer. The most frequent genetic mutation harboured in lung adenocarcinomas occurs in the epidermal growth factor receptor (EGFR), accounting for 40-55% in Asian patients.
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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.
An exploratory post-hoc analysis of the BEACON CRC study investigated the overall survival (OS) of encorafenib + cetuximab (doublet) and FOLFIRI (control) according to prior therapies (bevacizumab, oxaliplatin, FOLFOXIRI and anticancer therapy [ACT]) in BRAF V600E-mutant metastatic colorectal cancer (mCRC).
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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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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
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.
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 and PARP-inhibitors with chemoradiation therapy, and more. A summary of 36 oral presentations on NSCLC, SCLC, and Mesothelioma.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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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.
On 15 February 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of melanoma patients with lymph node involvement following complete resection.
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.
On 14 January 2019, the FDA approved cabozantinib (Cabometyx®, Exelixis) for hepatocellular carcinoma (HCC) patients previously treated with sorafenib.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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).
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.
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.
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.
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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.
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).
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.
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.
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.
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.
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).
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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.
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.
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 (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).
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 (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.
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).
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.
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.
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.
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.
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.
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 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).
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.
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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.
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).
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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.
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.
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