It's a mixed feeling! K drug small cell lung cancer phase III clinically reached PFS endpoint Miss OS endpoint.

Recently, Mercerton announced the results of its test results for Phase III clinical KEYNOTE-604 of its checkpoint inhibitor Keytruda (pembrolizumab) combination chemotherapy (etoposide-platinum drugs) for the treatment of a wide range of small cell lung cancer (ES-SCLC).
results showed that keytruda chemotherapy combination significantly improved patient progression-free survival (PFS) by significantly (HR-0.75, 95% CI, 0.61-0.91), but missed the main endpoint of overall survival (OS) (HR-0.80, 95% CI, 0.64-0.98).
KEYNOTE-604 was a randomized, double-blind, placebo-controlled Phase III study that recruited 453 SCLC patients who had not yet used systemic therapy to assess the effectiveness of Keytruda combined chemotherapy in patients with newly diagnosed small cell lung cancer compared to chemotherapy.
end points of the study were OS and PFS, and the secondary endpoints were objective mitigation rate (ORR), mitigation duration (DOR), safety, and quality of life.
is the same as PD-(L)1 therapy, inevitably compared.
in the IMpower133 study, the Roche Tecentriq treatment group reduced the risk of death by 30 percent compared to individual chemistry, and in the Caspian study, the AstraZeneca Imfinzi treatment group reduced the risk of death by 27 percent, both higher than Keytruda's 20 percent.
the study failed to reach the main OS endpoint, reducing the risk of cancer progression or death by 25 percent was more competitive than the other two PD-L1 drugs.
Tecentriq reduced the risk of disease exacerbating or dying by 23 per cent, and Imfinzi reduced the risk by 22 per cent. Dr. Roy Baynes, Chief Medical Officer, Senior Vice President and Global Head of the
Mercado Research Laboratory, said, "The results of KEYNOTE-604 demonstrate keytruda's association with chemotherapy and have the potential to improve disease progression and prognosis in patients with new diagnoses of widespread small cell lung cancer and highly aggressive malignancies.
, an analyst at SVB Leerink, said in an investor report that this alone was not enough to support clinical approval, especially as Tecentriq and Imfinzi had already achieved overall survival victories in the field.
Graybosch also said that if Keynote-604 is successful with the adaptation, sales in the U.S. could increase by another $269 million to $429 million by 2024.
said he would discuss the mixed results of the study with regulators and would announce the progress at an upcoming medical conference.
sources: 1, Merck's Keytruda Shows Mixeds in Lung Cancer Study 2, Keytruda Misses key lung cancer survival endpoint 3, Merck's Keytruda Misses key mark in small cell lung cancer trial, dashing big expansion hopes.