Merck’s KEYTRUDA ® wins EC approval for treatment of NSCLC patients
Category: #health  By Mateen Dalal  Date: 2019-03-16
  • share
  • Twitter
  • Facebook
  • LinkedIn

Merck’s KEYTRUDA ® wins EC approval for treatment of NSCLC patients
  • KEYTRUDA® combination significantly improved overall survival in adults with metastatic squamous NSCLC
     
  • Its safety in combination with chemotherapy was evaluated in 791 NSCLC patients in clinical studies

Merck has recently announced that its anti-PD-1 immunotherapy KEYTRUDA® has won approval from the European Commission (EC), for use in combination with paclitaxel or nab-paclitaxel and carboplatin in first-line treatment of adult patients having metastatic squamous non-small cell lung cancer (NSCLC).

EC’s approval was apparently based on the data from the Phase 3 KEYNOTE-407 trial, which showed that KEYTRUDA® helped in significantly improving overall survival (OS) in adults with metastatic squamous NSCLC, in combination with chemotherapy, irrespective of the status of PD-L1 tumor expression. It reduced the risk of death by 36% when compared to treatment using chemotherapy alone.

Merck informed that the safety of KEYTRUDA® in combination with chemotherapy was evaluated in 791 NSCLC patients, who received 200mg, 2mg/kg or 10mg/kg KEYTRUDA® every 3 weeks during clinical studies. This approval allows the marketing of the KEYTRUDA® combination across all 28 European Union member countries as well Iceland, Norway and Lichtenstein, at the approved dose of 200mg every 3 weeks until progression of disease or unacceptable toxicity.

To treat NSCLC, KEYTRUDA® is also approved in Europe as the first-line treatment of metastatic squamous or non-squamous NSCLC as monotherapy in adults with high PD-L1 tumor expression and no ALK or EGFR positive tumor mutations. It can also be deployed as a first-line treatment, in combination with pemetrexed and platinum chemotherapy, for metastatic non-squamous NSCLC in adults with no ALK or EGFR positive mutations in tumors.

Further, KEYTRUDA® has also been approved in the region for treating locally advanced or metastatic NSCLC in adult patients whose tumors express PD-L1 and also who have received at least one chemotherapy regiment previously.

Across the patient population in clinical studies, Merck said the most frequent adverse reactions observed were anemia, constipation, decreased appetite, diarrhea, fatigue, nausea and neutropenia. Occurrence of Grade 3-5 adverse reactions were 67%, while for chemotherapy alone they were 66%.

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

Ather Energy raises $250 million to stay ahead in competition
Ather Energy raises $250 million to stay ahead in competition
By Mateen Dalal

Electric scooter producer Ather Energy has reportedly secured $250 million in a new funding round. As per reports, the investment round is in its early stages. The company’s goal is to obtain $200 million to $250 million to compete in the EV...

Digital wellness startup Mojorcare bags USD 20 Mn in Series A funding
Digital wellness startup Mojorcare bags USD 20 Mn in Series A funding
By Mateen Dalal

Mojocare, a wellness and health startup has reportedly raised USD 20.6 million in a Series A round of funding which was led by B Capital Group and saw participation from existing investors including Sequoia India’s Surge, Better Capital, and Ch...

Exponent Energy bags USD 13 million in Lightspeed-led Series A funding
Exponent Energy bags USD 13 million in Lightspeed-led Series A funding
By Mateen Dalal

Bangalore-based Exponent Energy has reportedly secured USD 13 million in a Series A funding round which was spearheaded by Lightspeed Venture Partners. The round also saw participation from existing investors such as 3one4 Capital, YourNest VC, and A...