Merck's KEYTRUDA Plus Chemotherapy Approved by FDA

Merck's KEYTRUDA Plus Chemotherapy Approved by FDA

By, Admin 20 September 2024

Merck's KEYTRUDA Plus Chemotherapy Approved by FDA for Advanced Malignant Pleural Mesothelioma

Overview

Merck has received approval from the U.S. Food and Drug Administration (FDA) for its anti-PD-1 therapy, KEYTRUDA, in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

About KEYTRUDA

KEYTRUDA, an anti-PD-1 therapy, enhances the immune system’s ability to detect and fight cancer cells by blocking the interaction between PD-1 and its ligands.

Malignant Pleural Mesothelioma

Malignant pleural mesothelioma, which accounts for around 75% of all mesothelioma cases, is a rapidly progressing form of cancer that affects the lining of the lungs.

Behind the Approval

  • The approval is supported by results from the IND.227/KEYNOTE-483 trial, a pivotal Phase 2/3 study. 
  • The trial showed that combining KEYTRUDA with chemotherapy significantly improved overall survival (OS), reducing the risk of death by 21% compared to chemotherapy alone. 

Results

  • Median OS was 17.3 months for the KEYTRUDA combination, compared to 16.1 months for chemotherapy alone. 
  • The combination also showed a significant improvement in progression-free survival (PFS) and a higher overall response rate (ORR) compared to chemotherapy alone.

Adverse Reactions

  • Adverse reactions in patients receiving this combination were generally consistent with those previously observed in patients treated with KEYTRUDA and chemotherapy. 
  • Serious immune-mediated adverse reactions, which can affect multiple organs, may occur at any point during or after treatment. 

These reactions require early identification and management to ensure safe use of KEYTRUDA. The therapy may also cause severe infusion-related reactions and harm to a developing fetus if administered to pregnant women.

About IND.227/KEYNOTE-483 Trial

  • The IND.227/KEYNOTE-483 trial was conducted in collaboration with the National Cancer Institute of Naples (NCIN) and the Intergroupe Francophone de Cancérologie Thoracique (IFCT). 
  • The trial enrolled 440 patients with advanced or metastatic MPM, with no prior systemic therapy. 

Trial & Outcomes

  • Patients were randomised to receive either KEYTRUDA with pemetrexed and cisplatin or carboplatin, or chemotherapy alone. 
  • The main outcome measure was overall survival, with secondary outcomes including progression-free survival and overall response rate. 
  • Tumour assessments were conducted every six weeks for 18 weeks, and then every 12 weeks thereafter.

The five-year survival rate for malignant pleural mesothelioma in the U.S. from 2014-2020 was just 12.8%.

About Merck

Merck is currently running over 1,600 clinical trials to study KEYTRUDA across various types of cancer, aiming to understand the factors that influence a patient’s likelihood of benefiting from this treatment.

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