Immunotherapies like Opdivo® and Keytruda® were rapidly establishing themselves as the new Standard of Care for chemo pre-treated NSCLC. And both Merck and BMS kept the media busy with the readouts from Clinical trials in other cancers. ASCO 2016 contained a limited amount of groundbreaking data as the trials were mostly ongoing and mature data wasn't yet available. However, the 2016 conference allowed a sneak view of trends in oncology drug development. The most important question lurking in everybody’s mind was "Now that Immunotherapy is here, What next?"
ASCO saw the trend of using PD-1/PD-L-1s as a backbone for combination regimens with chemo, targeted therapy, and radiation. Of note was the combination of IOs with the IDO inhibitor, epacadostat which was studied in multiple open-label trials. Keytruda’s preliminary results in first-line NSCLC in combination with standard chemotherapy were noteworthy with an ORR of 71%.
Oncology market now was catered by multiple IO players like Opdivo®, Keytruda®, Tecentriq® each offering its own diagnostic assay to measure PD-L1 expression. From the discussions, it was clear that there was high ambiguity around the PD-L1 threshold values for each assay and there was no clear-cut way to recommend one assay over another. Amongst the discussions on available or upcoming immunotherapies, a clear need for standardization or simplification for PD-L1 biomarker assay was recognized.
In the EGFRm+ NSCLC space, a special panel concluded that first-generation EGFR inhibitors like erlotinib, gefitinib, and 2nd generation drugs like afatinib are interchangeable - something that the most clinicians already "knew". Even though AZ's osimertinib was the new poster child in EGFRm+ NSCLC, the company didn't emphasize on the drug during the entire event. The special independent panel presented its deliberations and the consensus on osimertinib's superior clinical benefit in T790M+ NSCLC patients.
Another key development was the introduction of liquid biopsies for testing. The speakers highlighted the fact that liquid biopsies were much quicker, simpler and easy on the pocket as compared to conventional standard tissue biopsies. In a historic event, the U.S. Food and Drug Administration (FDA) had approved the Cobas® EGFR mutation liquid biopsy test for Tarceva® earlier in June. However, the physician community was still divided in their opinions on the incremental utility of tumor DNA isolated from the blood over standard tumor biopsy. It was a general sentiment that more data is warranted to firmly put the topic of which is better, to rest.
Biosimilars, at ASCO 2016, for the first time, came to limelight and became the talk of the town (several talks if not "the" talk). Mylan’s Phase 3 clinical read on trastuzumab biosimilar elicited an enormous interest. All the biosimilar sessions and presentations throughout the conference commanded a full house attendance. The conversations were broad and deep covering scientific, medical and commercial topics.
Building upon the foundation set during ASCO 2015, health care economics, cost trends, new models for oncology payments, value rather than volume etc. enjoyed a significant interest during ASCO 2016. During the payer sessions, it became apparent that payers have been proactively developing their own value frameworks, care pathway algorithms, and methods to assess the cost-effectiveness of drugs. ASCO had earlier launched its Patient-Centered Oncology Payment (PCOP) in 2015. The plethora of drug pricing and reimbursement was such that, the ASCO community came up with an updated version of the PCOP framework based on cost-effectiveness and clinical efficacy of drugs. The main aim of the framework was to provide value based and affordable care to the patients, leading to improved patient outcomes.