Merck & Co., Inc.’s MRK and partner Eisai announced that the FDA has issued a complete response letter (CRL) to their applications seeking approval of a combination of its blockbuster PD-L1 inhibitor Keytruda and Eisai’s tyrosine kinase inhibitor, Lenvima for the new indication. The applications are seeking approval of Keytruda+Lenvima combination for the first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
The regulatory applications were based on data from the phase Ib KEYNOTE-524/Study 116. The CRL said that the regulatory applications did not provide enough evidence that the Keytruda+Lenvima combination shows any meaningful advantage over existing drugs for unresectable or metastatic HCC in patients who have not received prior systemic therapy. Please note that last month, the FDA approved Roche’s PD-L1 inhibitor, Tecentriq in combination with Avastin for first-line HCC treatment. The approval was based on data from the phase III IMbrave150 study, which showed that the Tecentriq +Avastin combination improved overall survival and progression-free survival compared to the standard of care
Merck and Eisai plan to conduct an additional study, which will provide proof of effectiveness and benefit of the combination drugs in this patient population. In this context, LEAP-002, a phase III study evaluating the Keytruda+Lenvima combination as a first-line treatment for advanced HCC is fully enrolled.
The combination of Lenvima and Keytruda is presently approved by the FDA for advanced endometrial carcinoma. Meanwhile, Lenvima is being studied in combination with Keytruda across 13 different tumor types including bladder, melanoma and NSCLC.
Merck’s shares have lost 14.3% this year so far compared with the industry’s 1.2% decline.
Keytruda, Merck’s biggest product, is already approved for use in 23 indications across several different tumor types in the United States.
Keytruda recorded sales of $3.3 billion in the first quarter of 2020, up 45% year over ear. The drug’s sales were driven by the launch of new indications globally. Keytruda sales, particularly, are benefiting from strong momentum in the first-line lung cancer indication.
The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1200 studies including 850 plus combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.
Undoubtedly, Keytruda’s solid growth prospects are based on increased utilization, approval for new indications and expectation of additional approvals worldwide. However, such pipeline setbacks do not bode well for the company.
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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