Merck (MRK, Financial) is preparing to release a subcutaneous version of its cancer therapy, Keytruda (pembrolizumab), as announced by CEO Robert Davis at the JPMorgan Healthcare Conference. The company aims to file for regulatory approval and launch this version by 2025, which is earlier than anticipated. This development follows the positive results from a Phase III study comparing the subcutaneous form, MK-3475A, with the intravenous version for first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults.
The study demonstrated that the subcutaneous injection is quicker, taking about 2-3 minutes, and offers similar efficacy and safety as the intravenous form, potentially enhancing patient experience and accessibility. Marjorie Green, head of oncology clinical development at Merck, highlighted that the subcutaneous version could significantly improve patient and healthcare provider access.
Keytruda generates annual sales of approximately $25 billion. However, with its patent set to expire in 2028, Merck faces significant competitive pressures. The subcutaneous version, which includes Alteogen's drug delivery compound berahyaluronidase alfa, is expected to be a critical strategy post-patent expiry, as it will not face immediate competition from generics unlike the intravenous form.
Furthermore, while the intravenous Keytruda might be subject to Medicare price negotiations in 2028, the subcutaneous version with its new component may avoid such discussions, allowing Merck to set favorable pricing terms for this more convenient option.
