By Rajaneesh K. Gopinath, Ph.D.
The 2019 Asian edition of the European Society for Medical Oncology Congress (ESMO Asia) brought together more than 3,500 medical professionals from the Asia Pacific and other regions to discuss the advances in cancer research and focus on the latest trends in oncology, drug development, and progress in clinical interventions in Asia.
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for about 85% of all lung cancer types, and EGFR and ALK are the most common genetic mutations in patients. This year, at the ESMO Asia, data from two major NSCLC Phase III clinical trials were presented.
ALTA-1L: Takeda’s Brigatinib Prolongs PFS in ALK-Positive NSCLC
An ongoing Phase III clinical trial, ALTA-1L involving ALK-positive NSCLC patients divided them into two groups with one receiving Crizotinib (138 patients) and the other, Brigatinib (137 patients). These patients were not been treated previously with an ALK inhibitor. It was found that Takeda’s ALK-targeted drug Brigatinib conferred a longer lasting progression free survival benefit vs. Crizotinib (67% vs. 43%; HR = 0.49; 95% CI: 0.33-0.74).
After more than 2 years of follow-up, Brigatinib reduced the risk of disease progression or death by 76% (HR = 0.24; 95% CI: 0.12-0.45) in newly diagnosed patients whose disease had spread to the brain at the time of enrollment. The risk of disease progression or death was also reduced by 57% in all other patients (HR = 0.43; 95% CI: 0.31-0.61).
ARCHER 1050: Dacomitinib Significantly Improves PFS and OS in Patients with EGFR-Mutant NSCLC
The Phase III clinical trial, ARCHER 1050 enrolled 452 patients with locally advanced or metastatic NSCLC with EGFR mutations. They were randomly assigned to receive dacomitinib (45 mg) or gefitinib (250 mg) from AstraZeneca at a 1:1 ratio. The results showed that the progression free survival in the dacomitinib arm was 16.5 months, which was significantly better than the 9.3 months in the gefitinib arm (HR = 0.509; 95% CI: 0.391-0.662; P <0.0001).
Further follow-up found that dacomitinib improved the overall survival (OS) in patients, with a median of 37.7 months vs. 29.1 months of gefitinib. Besides, the duration of response (DoR) in the dacomitinib group was longer than in patients treated with gefitinib, at 16.6 and 8.3 months, respectively.
New Study Combines miRNA and Deep Learning to Predict Patient Responses to Immunotherapy
Physician Chia-Hsun Hsieh, from the Department of Hematology and Oncology at the Chang Gung Memorial Hospital, Linkou discussed the use of small molecular ribonucleic acids (microRNA, miRNA) as biomarkers in the blood. He further explained how deep learning analysis can be used to correlate with clinical data and predict patient response to immunotherapy. Since the current response rate of PD-L1 immunotherapy is only about 20-25%, more accurate biomarkers are necessary to screen patients out. The data from the study is promising, with an accuracy rate of 80%, which is much higher than the existing biomarkers. miRNAs certainly have the potential to develop into precise biomarkers, with their inherent advantages such as non-invasiveness and easy access that evades problems with insufficient samples. Besides this presentation, Quaker Bio also displayed the miRNA results and early cancer screening tests at their booth set up in the Taiwan Medical Sciences and Technology section.
Progress in Hepatocellular Carcinoma (HCC) Research Could Revamp Treatment Guidelines
The primary analysis of Phase III IMbrave150 clinical trial results were presented by Prof. Ann Lii-Cheng, a cancer physician at the National Taiwan University. The trial data from around 500 people showed that the combination of PD-L1 inhibitor atezolizumab and VEGF inhibitor bevacizumab significantly improved the condition of unresectable hepatocellular carcinoma patients as compared to the current standard of care, sorafenib alone. The overall survival (OS) and progression free survival (PFS) were the coprimary endpoints of the study. This is the first time in ten years that a clinical trial with a new frontline therapy improved the survival rate of HCC. This might be possibly incorporated into existing treatment regimens by changing current treatment guidelines.
BeiGene’s Investigational PD-1 Inhibitor Goes Up a Notch
BeiGene, China, announced preliminary data from a Phase II clinical trial involving patients with gastric cancer, gastroesophageal junction (G/GEJ) adenocarcinoma, and esophageal squamous cell carcinoma (ESCC). The trial tested the humanized, anti PD-1 monoclonal antibody, Tislelizumab in combination with chemotherapy drugs such as Cisplatin, Capecitabine, Oxaliplatin or Fluorouracil (5-FU), etc. Preliminary data showed that 46.7% of patients achieved a partial response (PR). The G/GEJ adenocarcinoma group exhibited a progression free survival (PFS) of 6.1 months, while the ESCC group had a PFS of 10.4 months.
“In this trial, the combination treatment of tislelizumab and chemotherapy demonstrated durable responses and was generally well-tolerated in patients with G/GEJ adenocarcinoma or ESCC,” said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.
First China-made Trastuzumab Biosimilar Exhibits Excellent Clinical Performance
The results from a randomized phase III trial indicated that Trastuzumab’s biosimilar HLX02 displayed comparable performances in patients with HER2-positive relapses or previously treated patients with metastatic breast cancer. The overall response rate (ORR) was found to be similar at 24 weeks with HLX02 (71.0%) and Trastuzumab (71.4%, p=0.952). The incidence of adverse events was similar within the two groups, and there were no differences in safety or immunogenicity.
“Trastuzumab is not widely accessible around the world due to its high cost. The entry of more affordable versions of trastuzumab such as HLX02 could open up treatment access,” said the lead author of the study, Binghe Xu, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing. HLX02 has shown significant potential to reduce the spending on HER2-positive cancer treatments in the future.
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