[ESMO 2024] MSD remains cautious about when Keytruda’s SC formulation comes to market
BARCELONA, Spain -- By Kim Chan-hyuk/Korea Biomedical Review correspondent -- MSD provided an update on developing a subcutaneous (SC) formulation of its anti-PD-1 immuno-oncology drug Keytruda (pembrolizumab), during a press briefing at the European Society for Medical Oncology’s annual conference (ESMO 2024), in Barcelona, Spain, on Monday.
During the media event, Dr. Marjorie Green, MSD’s senior vice president for global clinical development in cancer therapeutics, and Dr. Scot Ebbinghaus, vice president for global clinical development, presented the latest advances in cancer care and strategies for expanding MSD's oncology portfolio. The event also marked the 10th anniversary of Keytruda's launch.
Since it won U.S. FDA approval in 2014, Keytruda has become an innovative treatment in immuno-oncology. Over the past decade, it has played an important role in improving patient survival across a range of cancers. Building on these achievements, MSD announced new therapeutic strategies centered around Keytruda and highlighted its plans to develop expanded therapies.
The MSD executives classified MK-3475A, Keytruda's subcutaneous formulation, as a late-stage candidate in phase 3 or phase 2/3 studies.
Korean journalists’ questions focused on the status of the development of the subcutaneous formulation of Keytruda, the timeline for completing specific clinical trials, the potential for further expansion of the collaboration with Korean biotech Alteogen, and how they assess Alteogen's technology.
In response, Dr. Green said, “The subcutaneous formulation is currently in clinical studies, and we expect to present clinical data soon. However, we can only rely on publicly available information as to when this will be completed,” avoiding commenting on a specific timeline.
“Many patients prefer a simpler treatment than having a port inserted or receiving an IV infusion. Any treatment that can provide the same benefits without the need for IVs, especially in treatments intended to be curative, will add great value to patients and providers alike,” she added.
Commenting on the possibility of expanding the collaboration with Alteogen, Greene also said, “I can't speak specifically to the possibility of expanding the collaboration at this time. We will always make announcements when we are ready to do so.”
Green said of MSD's development strategy: “With Keytruda, MSD continues exploring ways to strengthen the immune system further and enable it to recognize and attack cancer cells more effectively.”
She emphasized that MSD is exploring new possibilities for cancer treatment with a range of immuno-oncology and precision-targeted therapies.
Dr. Ebbinghaus said, “We expect more than 30 new drug candidates in the pipeline over the next five to six years to bring significant advances to cancer treatment, giving patients more options.”
MSD and Alteogen have collaborated through a license agreement for ALT-B4, a human hyaluronidase technology.
In a recent amendment to the agreement, MSD was granted exclusive rights to the subcutaneous formulation of Keytruda being developed using ALT-B4, for which Alteogen received an upfront payment of $20 million. Alteogen is also eligible to receive up to an additional $432 million in milestones based on future product approvals, cumulative sales, and sales royalties.