Merck's Keytruda Gains FDA Approval for Rare Cancer Treatment

Author: Evelyn Baker Updated: 09-18-2024 02:57 PM

Merck's Keytruda Gains FDA Approval for Rare Cancer Treatment

Recently, Merck & Co Inc's Keytruda (pembrolizumab) has achieved a remarkable milestone by securing FDA approval. This approval allows for its use in combination with pemetrexed and platinum chemotherapy to treat adult patients suffering from unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

First Approval for MPM Treatment

This is a groundbreaking achievement as it marks the first time Keytruda has been indicated for the treatment of MPM in the United States. MPM is an aggressive cancer that develops in the lining of the lungs and chest, presenting significant challenges for both patients and healthcare providers.

Trial Data Highlights

The FDA's decision is supported by crucial data from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial. The findings revealed that the combination of Keytruda and chemotherapy significantly improves overall survival rates. Specifically, patients receiving this treatment experienced a risk of death reduced by 21% when compared to those receiving chemotherapy alone.

Overall Survival Rates

In the study, the median overall survival (OS) for patients treated with Keytruda and chemotherapy was reported as 17.3 months, whereas the cohort receiving chemotherapy alone had a median OS of 16.1 months. This 1.2-month difference signifies a notable enhancement in life expectancy for MPM patients.

Progression-Free Survival Enhancements

Moreover, the treatment regimen incorporating Keytruda also demonstrated significant improvements in progression-free survival (PFS) compared to chemotherapy alone. The overall response rate (ORR) was found to be 52% for those receiving the combination therapy, compared to just 29% for chemotherapy alone, indicating a marked increase in treatment efficacy.

Adverse Reactions and Ongoing Research

The profile of adverse reactions in MPM patients treated with Keytruda was consistent with those seen in other studies utilizing Keytruda in combination with pemetrexed and platinum chemotherapy. These findings provide reassurance regarding the safety of this treatment approach.

While this approval is a significant victory for Merck and its ongoing efforts in cancer research, it’s noteworthy that the company recently discontinued two late-stage studies of Keytruda due to underwhelming data outcomes.

Discontinued Trials

The Phase 3 KEYNOTE-867 trial was evaluating Keytruda in conjunction with stereotactic body radiotherapy for non-small cell lung cancer stages I or II.
The Phase 3 KEYNOTE-630 trial was focused on the adjuvant treatment of high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) after surgery and radiation.

Impact on Stock Performance

Following the announcement of this FDA approval, MRK stocks experienced a slight increase, trading 0.04% higher at $118.34. This positive reaction reflects investor confidence in the potential of Keytruda to make impactful strides in cancer therapy, especially with this new approval.

Future Perspectives

As Merck advances its commitment to providing effective therapies, this approval for Keytruda in treating malignant pleural mesothelioma represents hope for patients affected by such a devastating disease. Continued research and development in this area could lead to even more treatment options that expand survival and enhance the quality of life for those diagnosed with MPM.

Frequently Asked Questions

What is Keytruda used for?

Keytruda is an immune checkpoint inhibitor used to treat various cancers, including malignant pleural mesothelioma, often in combination with chemotherapy.

How does Keytruda work?

Keytruda works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively.

What is malignant pleural mesothelioma?

Malignant pleural mesothelioma is a rare and aggressive cancer that develops in the lining of the lungs and chest, often caused by asbestos exposure.

What are the side effects of Keytruda?

Common side effects of Keytruda include fatigue, rash, and immune-related reactions, which can be managed under medical supervision.

What recent developments have occurred with Merck?

Recently, Merck achieved FDA approval for Keytruda in treating MPM and also discontinued two late-stage trials due to underperformed results.

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Merck's Keytruda Gains FDA Approval for Rare Cancer Treatment