Significantly extendo OS! Sanofi/Regenerative Element PD-1 Lung Cancer Phase III Clinical Early Termination.

Sanofi and Regenerative Yuan have announced that their PD-1 inhibitor Libtayo beat chemotherapy in a Phase III clinical trial of a first-line treatment for non-small cell lung cancer (NSCLC), significantly extending the total survival (OS) of patients.
, on the recommendation of the Independent Data Monitoring Committee, the two companies plan to terminate the trial early so that all patients in the group can receive Libtayo treatment.
Libtayo (cemiplimab) is the sixth PD-1/PD-L1 inhibitor to go to market and has been approved for use in adult patients with metastatic or localized advanced skin squamous cell carcinoma, but has not missed out on the high-profile lung cancer market. The clinical trial, disclosed by
, is an open-label, randomized, multi-center Phase III study in patients with tumor cell PD-L1 expression with a rate greater than or equal to 50%, untreated squamous or non-scaly late-stage NSCLC, comparing the efficacy and safety of Libtayo with platinum-containing chemotherapy, with the main endpoint being OS.
results showed that Libtayo significantly extended the patient's OS.
, Libtayo reduced the risk of death by 32.4 per cent.
so far, Sanofi and Regeneration have yet to publish more detailed results, and cross-trial data comparisons are difficult to give due to design differences and the specificity of patient data.
, Sanofi's head of research and development, said the trial was the largest of its kind worldwide and said the results were "very encouraging."
such a good survival extended performance, may put pressure on Mercer's owner, Keytruda.
for the same target population, Keytruda reduced the risk of death by 31% in the Keynote-042 trial.
, Keytruda continues to have a reduced risk of death for PD-L1, which is expressed in 20%, and the 1% patient population.
it is understood that Sanofi and Regenerative Sym have removed the restrictions on PD-L1 high expression in patients targeted at the trial, further expanding the trial population, with the aim of again matching Keytruda's Keynote-042 study.
currently, most lung cancer patients opt for Keytruda combined with chemotherapy rather than Keytruda single-drug therapy.
clinical data showed that Keytruda combined chemotherapy reduced the risk of death by about 50 percent compared to chemotherapy, regardless of PD-L1 expression.
Sanofi and Regenerative Yuan are not the only companies trying to challenge Keytruda's single-drug therapeutic status.
's PD-L1 inhibitor Tecentriq is also moving closer to the higher-order areas of single-drug first-line treatment, with the FDA due to announce Tecentriq's approval by June 19.
the IMpower110 study, Tecentriq extended patients' survival by an additional 7.1 months and reduced the risk of death by about 40 percent compared to chemotherapy.
based on this encouraging clinical results, Sanofi and Regenerative plans to submit current data to the U.S. and the European Union this year for listing approval.
sources: 1, Sanofi, Regeneron take aim at Keytruda with Libtayo's first lung cancer win 2, Sanofi: Phase 3 trial of Libtayo® (cemiplimab) asthe monorapy for first-line non-small cell lung cancer stopped all due to highly highly highly high-level property.