K drug small cell lung cancer PHASE III clinical reach PFS endpoint miss OS endpoint
Last Update: 2021-03-03
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, Mercadon announced the results of its checkpoint inhibitor Keytruda (pembrolizumab) combined chemotherapy (etoposides and platinum drugs) to treat a wide range of small cell lung cancer (ES-SCLC) Phase III clinical KEYNOTE-604 trial results. The results showed that the Keytruda chemotherapy combination achieved a significant increase in the primary endpoint of patients' progress-free survival (PFS) (HR=0.75,95% CI, 0.61-0.91), but missed the primary endpoint of total lifetime (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 system therapy to evaluate the effectiveness of Keytruda combined chemotherapy in patients with newly diagnosed, widespread stage small cell lung cancer compared to chemotherapy. The dual endpoints of the study were OS and PFS, and the secondary endpoints were objective mitigation rate (ORR), mitigation duration (DOR), safety, and quality of life.
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, up from 20 percent for Keytruda.
Although the study failed to reach the main OS endpoint, reducing the risk of cancer progress or death by 25 percent was more competitive than the other two PD-L1 drugs. Tecentriq reduced the risk of disease worsening or death by 23 per cent, and Imfinzi reduced the risk by 22 per cent.
Dr. Roy Baynes, Chief Medical Officer, Senior Vice President and Global Director, Mercado Research Laboratory, said, "The KEYNOTE-604 results demonstrate keytruda's combination with chemotherapy and has the potential to improve disease progression and prognosis in patients with newly diagnosed, widespread small cell lung cancer and highly invasive malignancies.
that alone is not enough to support clinical approval, especially as Tecentriq and Imfinzi have already achieved overall survival victories in the sector,
SVB Leerink analyst Daina Graybosch said in an investor report. Graybosch also said that if Keynote-604 succeeds in the allergy, the drug's U.S. sales could increase by another $269 million to $429 million by 2024.
Mr Mercedon said it would discuss the mixed results of the study with regulators and would announce progress at an upcoming medical conference. (Sina Pharmaceutical News)
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