Is There a Future for Sintilimab/Chemo in US Patients With Nonsquamous NSCLC?


Jorge Nieva, MD, discusses what’s needed for frontline sintilimab plus chemotherapy to have a future in United States patients with nonsquamous non–small cell lung cancer after a negative ODAC vote.

Jorge Nieva, MD, associate professor of Clinical Medicine at the Keck School of Medicine of University of Southern California, discusses the recent biologics license application for sintilimab (Tyvyt) injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with nonsquamous non–small cell lung cancer (NSCLC), and what’s needed for the drug to have a future in the US after a negative vote from the FDA’s Oncologic Drug Advisory Committee.

The committee voted was 14 to 1 in favor of more research to support a future FDA approval for the sintilimab combination during a February meeting. Committee members raised questions about the validity of the ORIENT-11 data submitted with the biologics license application and how a future clinical trial should look for the agent.

Nieva, being the 1 committee member who voted that no additional data should be required, explains the need for diverse trial populations and better end points.


0:08 | We want drugs tested in ethnically diverse populations. I think it was less important for suntilimab than for some other drugs, because it was a me-too drug. And because it wasn't a novel molecular entity. I think I would have been completely onboard with the other groups, the rest of the group's decision making if this had been a novel, small molecule, or something with a novel mechanism of action, but this drug was neither of those things.

0:45 | So, I think it's a real challenge now to ask how you would test the drug in lung cancer in the metastatic setting and do it in a global way, with a diverse population unless you go back into those countries that don't have access to PD-1 inhibitors and try to replicate the design.

1:11 | I think the FDA was not happy with the design because it was an outdated design. It was a design based on the standard of care back in 2016 and not the standard of care in 2021. I don't think you really can design something with a 2021 standard of care with a survival or a PFS end point anymore. I just don't think it's possible unless you go to these underserved nations that don't have access to these medications. But I don't know if that was really the goal of the discussion.

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