The Biotech’s Conundrum in Immuno-Oncology: Weighing Hot Versus Cold Tumors, CPI-Naïve Versus CPI-Experienced Patients

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  • Jeff Bockman, PhD, EVP, Oncology Practice, Cello Health BioConsulting, Previously Defined Health


  • Mike Curran, PhD, Associate Professor, Immunology, MD Anderson
  • Emmett Schimdt, MD, Associate Vice President, Merck
  • Vanessa Lucey, PhD, Director, CRI Venture Fund and Clinical Accelerator, Cancer Research Institute
  • Steve Worland, PhD, President and CEO, eFFECTOR Therapeutics

The advent of the age of Immuno-Oncology (IO) has led to a dramatic shift in our conception of how to treat cancer patients. The approval of six checkpoint inhibitors (CPIs) in the US has in some tumor types transformed clinical management and patient outcomes (e.g., melanoma, non-small cell lung) but in other indications the clinical benefit has been more modest or even negligible. The need, by and large, to expand responsiveness and extend duration of remissions across all cancer, the so-called “hot” through to the “cold” tumors, has resulted in an intensive clinical development push around combinations. With the two leading CPIs Merck’s Keytruda and BMS’ Opdivo leading the way here with some 1400 combination trials ongoing, a diverse array of approaches – targets, modalities – are being combined with CPIs. The challenge for a well-resourced BioPharma owning a CPI (let alone not having one) in devising the clinical development strategy is complicated enough – which tumors, lines, what standard of care (SOC) or novel combinations to add on top of? But for the typically time and finance constrained precommercial biotech, these questions are not just of paramount importance, they are critical, often “life and death” decisions for the biotech, with the readouts significantly affecting value, perhaps inflecting, perhaps deflecting it. Hence, issue of whether to go for hotter or colder tumors, to go early line in checkpoint-naïve patients or in later lines in CPI-experienced patients, can engender heated internal dialogue amongst the team as issues of risk and timing and trial costs are debated. This webinar, with esteemed colleagues from Merck, MD Anderson, f-star, eFFECTOR and CRI, is intended to be a lively discussion of the pros and cons, challenges and opportunities that these various clinical development strategies entail.