14 to 1 Where did Cinda PD-1 lose?

The winter is bitter, and 2022 will be even colder

At 23:00 on February 10, 2022, Beijing time, the FDA held an ODAC meeting to review Innovent's Sintilimab

Ultimately, the committee voted 14 in favor and 1 against, requiring additional data from the ORIENT-11 clinical trial conducted in a single foreign country to demonstrate the applicability of sintilimab in the U.

Although the ODAC vote is not binding on the FDA's decision, the result is almost certain that Innovent/Lilly's PD-1 inhibitor will be rejected by the FDA

Where did Cinda PD-1 fail?

Despite the unsatisfactory results, Innovent Bio is worthy of respect as a pioneer of innovative drugs in China

ORIENT-11 is a randomized, double-blind, placebo-controlled phase III clinical trial conducted in mainland China, aiming to evaluate the efficacy of Xinlimab combined with pemetrexed and platinum-based chemotherapy in EGFR/ALK-negative, advanced or Efficacy and safety in first-line treatment of recurrent non-squamous non-small cell lung cancer, with the primary clinical endpoint being progression-free survival (PFS)

Primary study endpoint

The updated data showed that, as of May 15, 2020, with a median follow-up of 14.

Secondary Study Endpoint

The results of the end-of-OS analysis of the study have been published

The results of the median analysis were clearly biased towards the Xinlimab group

The ORIENT-11 results are encouraging, and the FDA has no questions about the safety and efficacy of sintilimab

However, its experience of setbacks in its overseas debut needs to be learned by other Chinese innovative drug companies that are ready to go

Moreover, the FDA emphasized that the price factor will not be considered in the review.

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