Summit Therapeutics' Lung Cancer Candidate Surpasses Merck's Multi-Billion Dollar Keytruda, Cuts Risk Of Disease Or Death By Half

Core Insights - Summit Therapeutics Inc. released positive data from the Phase 3 HARMONi2 trial of ivonescimab, showing significant efficacy against Merck's Keytruda in treating non-small cell lung cancer [1][2] Trial Results - Ivonescimab demonstrated a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.51, reducing the risk of disease progression or death by 49% compared to Keytruda [2][3] - The median PFS for ivonescimab was 11.14 months, compared to 5.82 months for Keytruda [3] - The overall response rate (ORR) for ivonescimab was 50% versus 38.5% for pembrolizumab, and the disease control rate (DCR) was 89.9% compared to 70.5% [4] Future Plans - Summit plans to initiate the HARMONi-7 trial in early 2025, comparing ivonescimab monotherapy to pembrolizumab in patients with high PD-L1 expression [5] - Data from a Phase 2 trial of ivonescimab alone or in combination with chemotherapy in resectable non-small cell lung cancer was also shared [5] Safety and Efficacy in Neoadjuvant Setting - In a cohort of 39 patients receiving ivonescimab plus chemotherapy, 71.8% experienced a major pathological response, and 43.6% had a pathological complete response [6] - The median event-free survival (EFS) was not reached after 8.9 months of follow-up, with a 12-month EFS rate of 80.3% [7] - The safety profile was manageable, with no treatment-related adverse events leading to surgery delays or patient deaths [7] Market Reaction - Following the announcement, SMMT stock rose by 30.4%, reaching $16.00 in premarket trading [7]