Summit Therapeutics and Akeso's Ivonescimab Outperforms Keytruda in NSCLC Treatment Trial
In a groundbreaking clinical trial, Summit Therapeutics and Akeso's Ivonescimab, a bispecific monoclonal antibody, has demonstrated superior efficacy in treating non-small cell lung cancer (NSCLC) patients compared to Merck's Keytruda. The Phase III HARMONi-2 trial, conducted in China with 398 enrolled patients, revealed that Ivonescimab significantly extended median progression-free survival (PFS) to 11.14 months, outperforming Keytruda's PFS of 5.82 months. Ivonescimab also achieved a higher overall response rate (ORR) of 50.0% compared to Keytruda's 38.5%.
However, safety concerns arose as a higher proportion of patients in the Ivonescimab group experienced grade 3 and above treatment-related adverse events (TRAEs) in comparison to the Keytruda group. Despite these findings, the US FDA might necessitate additional multiregional trials for approval, as observed with Eli Lilly's PD-1 inhibitor.
Summit is now preparing for HARMONi-7, focusing on patients with a PD-L1 Tumor Proportion Score (TPS) of 50% and above. If consistent results are obtained, Ivonescimab could potentially revolutionize NSCLC treatment, posing a threat to Keytruda's dominance in the market, with projected global sales of $1.7 billion by 2030.
Key Takeaways
- Ivonescimab demonstrated superior median progression-free survival (PFS) of 11.14 months, outperforming Keytruda's 5.82 months in NSCLC patients with a PD-L1 tumor proportion score above 1%.
- The trial enrolled 398 patients in China, and Ivonescimab achieved a 50.0% overall response rate, surpassing Keytruda's 38.5%.
- Safety concerns arose, with 29.4% of Ivonescimab patients experiencing grade 3+ treatment-related adverse events, compared to 15.6% with Keytruda.
- FDA approval might be unlikely based on the China-only trial, prompting Summit to plan a multiregional HARMONi-7 trial for broader approval.
- Ivonescimab is projected to reach $1.7 billion in global sales by 2030, challenging Keytruda's market dominance.
Analysis
Summit Therapeutics and Akeso's Ivonescimab poses a significant threat to Merck's Keytruda, potentially reshaping the NSCLC treatment landscape. The superior efficacy in China, despite safety concerns, could lead to multiregional trials, delaying US approval. If successful, Ivonescimab's $1.7 billion market potential by 2030 could disrupt Merck's dominance, impacting its revenue and stock. Investors should monitor HARMONi-7 results, which could influence biotech sector valuations and investor sentiment.
Did You Know?
- Ivonescimab: A bispecific monoclonal antibody targeting both PD-L1 and another protein, potentially enhancing its ability to treat cancer by engaging multiple pathways simultaneously.
- PD-L1 Tumor Proportion Score (TPS): A biomarker used to assess the level of PD-L1 expression on tumor cells, indicating the potential response to PD-1/PD-L1 inhibitors.
- Progression-Free Survival (PFS): A key clinical endpoint measuring the time from treatment initiation to disease progression or death, indicating the treatment's effectiveness in delaying disease progression.