The US Food and Drug Administration (FDA) has approved MSD’s KEYTRUDA regimen as a first-line treatment for adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
An anti-programmed death receptor-1 (PD-1) therapy, the treatment is indicated for use in combination with pemetrexed and platinum chemotherapy.
The approval for the KEYTRUDA regimen is supported by the results from the Phase II/III IND.227/KEYNOTE-483 clinical trial.
The study was a collaborative effort involving CCTG, Intergroupe Francophone de Cancérologie Thoracique and the National Cancer Institute of Naples.
MSD provided both the medication and additional support for the trial.
The Phase III segment of the IND.227/KEYNOTE-483 trial enrolled 440 patients who had not received prior systemic therapy for their advanced MPM.
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Participants were randomly assigned to receive either KEYTRUDA with chemotherapy or chemotherapy alone, with all treatments administered via intravenous infusion.
The combination led to a statistically significant improvement in overall survival (OS), with a 21% decline in mortality versus chemotherapy alone.
The median OS was reported to be 17.3 months for patients in the KEYTRUDA combination arm versus 16.1 months for those on treatment with chemotherapy alone.
KEYTRUDA plus chemotherapy also showed a significant enhancement in progression-free survival and overall response rate compared to chemotherapy alone.
KEYTRUDA’s safety profile in MPM patients was found to be in line with that observed in other cancers when used in conjunction with pemetrexed and platinum chemotherapy.
It operates by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, activating T lymphocytes to detect and combat tumour cells.
Merck Research Laboratories oncology clinical research vice-president Dr Gregory Lubiniecki stated: “We’re pleased to offer a new first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a disease where prognoses are generally poor.
“This milestone underscores our commitment to advancing research for patients with difficult-to-treat tumours.”
In July 2024, MSD acquired Eyebiotech (EyeBio) in a deal totalling $1.3bn, making the company its subsidiary.
