FDA Approves KEYTRUDA Combo For Advanced Lung Cancer Treatment

Merck (NYSE: MRK), known as MSD internationally, has received approval from the U.S. Food and Drug Administration (FDA) for its immunotherapy, KEYTRUDA, in combination with pemetrexed and platinum-based chemotherapy. This treatment is now cleared for first-line use in adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM), a type of cancer affecting the lining of the lungs.

The FDA's approval was supported by results from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial. This study showed that adding KEYTRUDA to chemotherapy led to a 21% reduction in the risk of death (HR=0.79 [95% CI, 0.64-0.98]; p=0.0162) compared to chemotherapy alone, with a median overall survival (OS) of 17.3 months for the combination treatment versus 16.1 months for chemotherapy alone. 

Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories, said in a statement “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 tumors.”

Progression-free survival (PFS) also improved, with the combination therapy demonstrating a hazard ratio of 0.80 (95% CI, 0.65-0.99; p=0.0194) and a median PFS of 7.1 months, matching that of chemotherapy alone. Furthermore, the overall response rate (ORR) was notably higher for the KEYTRUDA combination at 52% compared to 29% with chemotherapy alone (p<0.00001). The side effects observed in patients with MPM were consistent with those seen in other patients treated with KEYTRUDA and chemotherapy.

Serious or even fatal immune-related side effects can arise during or after treatment with KEYTRUDA, potentially affecting multiple organs or systems at once. These reactions can occur at any time and may involve conditions like pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin disorders, organ transplant rejection (including solid organ and corneal grafts), and complications following allogeneic hematopoietic stem cell transplants. The immune-related risks listed here do not cover all possible severe outcomes. 

Prompt recognition and management of these adverse effects are crucial for the safe use of KEYTRUDA. Depending on the severity, treatment may need to be paused or discontinued, with corticosteroids administered if necessary. Additionally, KEYTRUDA can lead to severe or life-threatening infusion reactions and, due to its mode of action, may cause harm to a fetus if given to a pregnant woman. For more detailed safety information, refer to the “Selected Important Safety Information” section below.