Dmitry Kravchenko: Earlier-Line CAR-T – A Translational and Development Inflection Point
Dmitry Kravchenko, Oncologist, Medical Monitor at R-Pharm, posted on LinkedIn:
”Earlier-Line CAR-T: A Translational and Development Inflection Point
The push for CAR-T in 1L/2L therapy is inevitable. But as a strategy, it’s incomplete without a parallel evolution in our development paradigm.
This shift demands a strategic pivot in how we define success:
Beyond OS: In earlier lines, overall survival is confounded by subsequent therapies. The new pivotal endpoints must be translational surrogates for cure: e.g., sustained MRD negativity, durable CR rates, and novel biomarkers (e.g., CAR-T persistence/phenotype) that predict long-term benefit.
The Long-Term Risk-Benefit Calculus: Introducing potent cellular therapy to treatment-naïve patients changes the risk landscape. The long-term sequelae of CRS/ICANS and persistent immunologic effects could impact eligibility for future therapies. Our development plans must prospectively model this entire journey, not just the PFS curve.
The opportunity is monumental, but capturing it requires a First-in-Human (FIH) and early-phase mindset: designing trials that are not just dose-finding, but deeply biomarker-driven, with integrated PROs and long-term safety to truly understand the therapeutic profile.
How we redesign development to prove its transformative value?”
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