Bristol Myers Squibb Submits Phase III Trial Protocol for PD-1/LAG-3 Combination vs. Keytruda in First-Line NSCLC

▎Armstrong

On September 17, 2024, Bristol-Myers Squibb provided a comprehensive overview of the latest data presented at the ESMO conference, along with an introduction to its strategic layout and recent advancements in the field of oncology.

Nivolumab has fallen behind in the competition with Keytruda, but Bristol-Myers Squibb is looking for new breakthroughs, especially in the core battleground of first-line NSCLC.Bristol-Myers Squibb has chosen a combination therapy of PD-1 and LAG-3, with the enrollment criteria for its first Phase III clinical trial focused on non-squamous NSCLC patients with PD-L1 expression levels between 1-49%.

The design of Phase III clinical trials is based on the data from Phase II clinical trials.

Standard treatment with PD-1 + chemotherapy, adding LAG-3 did not increase side effects.

PD-1+LAG-3+ Chemotherapy Brings Clinical Benefits, Especially in Non-Squamous NSCLC Patients.

For non-squamous NSCLC patients with PD-L1 1-49%, the ORR increased from 30% to 60.7%, and the mPFS extended from 5.5 months to 9.8 months, with an HR of 0.45.

This is also the best efficacy data in history for this patient population.

For non-squamous NSCLC patients with PD-L1≥50%, ORR and mPFS also showed improvement, but not as much as in the patient population with PD-L1 1-49%.

Summary

Bristol-Myers Squibb Hopes That PD-1+LAG-3 Can Defeat Keytruda's Position in First-Line NSCLC. Based on Phase II Clinical Results, the Company Conservatively Limited the Patient Population to Those with PD-L1 1-49%, and Plans to Subsequently Expand Coverage by Conducting Separate Studies for Patients with PD-L1 ≥50%. The Combination of PD-1+TIGIT Was Highly Anticipated Due to Phase II Clinical Data, But Has Faced Continuous Setbacks in Phase III Trials. There Is High Expectation That Bristol-Myers Squibb’s PD-1+LAG-3 Could Bring a Breakthrough for First-Line NSCLC. Additionally, Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Achieved a Final mPFS Victory Over Keytruda in Phase III Clinical Trials. Cancer Immunotherapy May Witness More Clinical Breakthroughs, Accelerating the Transition Into the Post-PD-1 Era.