Journey through ASCO 2015 to 2017

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The American Society of Clinical Oncology (ASCO) is an organization representing physicians who specialize in the care and treatment of cancer patients. Over the years, ASCO has become a huge event which attracts anywhere between 30,000 and 40,000 visitors from the entire healthcare value chain - Physicians, Patients, Pharma, Payers, Investors, Regulators, Analysts etc.

@ASCO15 – Illumination and Innovation; transforming data into learning

ASCO 2015 was majorly focused on innovation. Going down the memory lane, I still remember the highly vibrant and charged atmosphere. Immunotherapy was "the" topic in 2015 - one of the biggest advancements in the history of medical research and innovation. Yervoy® and Opdivo® were already on the market since 2014 for melanoma. It was in 2015 that the buzz became a scream – Keytruda® and Opdivo® presented their lung cancer data. Opdivo's launch in lung cancer space created a near revolution in the market. While Keytruda's data was equally impressive, it was Opdivo that was seen as nothing short of a “miracle drug”. All the sessions pertaining to immunotherapy were packed to capacity. Merck and BMS excitedly communicated their data, the hope for a better treatment among physicians, patients, and patient advocacy groups started increasing rapidly. As it should be, with all the excitement came “Caution”. While some physicians were ready to adopt the therapy itself, others either had no or limited idea about IOs. There were some steaming questions as What is the MOA? Is it safe? Will it work? Whom to give? What if it did not work? When to give? How to manage the side effects?ASCO 2015 was also the first conference where INN name for “MPDL 3280A i.e. atezolizumab” was revealed. Some major data readouts were of Opdivo’s (CM-067 Melanoma, CM-057, and CM-017 NSCLC), Tecentriq’s (POPLAR and FIR NSCLC) and Keytruda’s (KN-012 NSCLC).ASCO 2015 also saw severe criticism of high-priced drugs and immunotherapy was no exception. Despite the buzz and excitement, cost effectiveness and affordability of innovative treatments were questioned. Some real-world studies on cost -effectiveness of available treatment options were applauded. The topics around cost-effectiveness and value-based pricing were discussed throughout the conference. All these talks set up the foundation stone for a value-based framework that ASCO launched in 2016.Amidst the buzz and excitement of immunotherapy, “Biosimilars” held its own, albeit somewhat dormant. Though Zarzio® was already approved, there was no major buzz around biosimilar medicines, as a class, other than companies like Hospira and Amgen mentioning then in their presentations. Most of the Biosimilar conversation took place in "satellite" symposia/presentations i.e. outside the McCormick Center.ASCO15 concluded on a hugely positive note. Immunotherapies gave hope, promise and bright future to cancer patients. At the same time, the ground was set to develop care frameworks that will enable broader, affordable access to high-impact treatments for individuals and societies alike.

@ASCO16 – Collective Wisdom; The future of patient-centered care and research

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.

@ASCO17 – Making A Difference In Cancer Care With You -Expectations and Outlook

In ASCO 2017, it will be great to see the new treatment options i.e. IOs and their combinations paving their way in other tumors. It would be informative to see how the disease landscape has evolved with the advent of IOs in the last one year. Equally, it would be very interesting to know how IOs are shaping the treatment paradigm in lung cancer and melanoma. As ASCO 2017 will progress, the preliminary data on IO combinations across tumor types will unfold. The conference will answer some burning questions on how to sequence the currently available therapies to achieve maximum patient benefit. There has been a huge advancement of liquid biopsies from ASCO 2016. Liquid biopsies now form part of initial screening before tissue biopsies. It will be really informative to see the companies presenting data on advancements in liquid biopsies. Accompanying this article, we are presenting our take on the noteworthy readouts of early stage molecules that bode well for cancer care in the near-term future. Discussions on value based frameworks are of paramount interest for patients as well as payers alike. ASCO 2017 will shed some light on the adoption of ASCO’s value based framework over one year and its related cost savings. The discussion on ASCO’s value framework versus ESMO’s Magnitude of Clinical Benefit Scale will be exciting.

RAS LSS Consulting would be attending ASCO this year too at Chicago. Stay tuned for live updates #ASCO17

Sakshi Saini
Sakshi Saini
Sakshi has a passion for healthcare and innovation in medical techs (Rx and devices). Her ability lies in providing an "outside-in" perspective to colleagues involved in the design, development and commercialization of medical innovation. She comes with a wide range of experience in the oncology space pertaining to both solid tumors and blood malignancies (Lung, Colorectal, Melanoma,AML and MDS).She works with RAS clients to provide activities related to market research and competitive intelligence. She is also a member of European Society of Clinical Oncology.

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