Merck's subcutaneous formulation of Keytruda has achieved positive results in a Phase III trial, demonstrating comparable efficacy to the intravenous version when administered with chemotherapy for first-line metastatic non-small cell lung cancer (NSCLC). The MK-3475A-D77 trial evaluated the subcutaneous formulation of Keytruda, combined with Alteogen’s berahyaluronidase alfa to support subcutaneous delivery, against intravenous Keytruda, both in conjunction with chemotherapy.
The trial met its primary endpoint, confirming that subcutaneous administration of Keytruda every six weeks performs as well as the intravenous infusion. Additional safety and efficacy endpoints were also met. This subcutaneous option offers a potentially less invasive administration route, which could be more convenient for patients and healthcare providers.
Potential Impact on Keytruda's Market Longevity
With Keytruda's exclusivity set to expire in 2028, Merck is exploring various strategies to maintain its market presence. BMO Capital Markets analysts suggest that the subcutaneous formulation could help sustain Keytruda's revenue stream by offering an alternative administration method that may appeal to patients and doctors. Guggenheim analysts highlighted the results as "an important step for the longevity of the Keytruda franchise."
Expanded Access and Patient Convenience
Merck executives estimate that up to 50% of patients could be candidates for the subcutaneous formulation. This could particularly benefit regions with limited access to infusion centers, potentially expanding access to Keytruda treatment. The convenience of subcutaneous administration may also improve patient adherence and quality of life.
Ongoing and Future Studies
Merck is also evaluating the subcutaneous version of Keytruda as a monotherapy in a Phase III trial for first-line NSCLC patients with a positive tumor proportion score. Additionally, Phase II trials are underway for relapsed and refractory Hodgkin’s lymphoma and primary mediastinal large B-cell lymphoma. Guggenheim analysts anticipate that the FDA may ultimately approve the subcutaneous formulation for all indications currently approved for the intravenous version, similar to the approval pathway for Roche’s Tecentriq.
Financial Implications
While the introduction of subcutaneous Keytruda may not fully offset expected revenue declines following Keytruda's loss of exclusivity, it could mitigate the speed of these declines. This would provide Merck with additional time to develop and market other key assets, such as Winrevair and Capvaxive, according to BMO Capital Markets.
