Merck Stalls Enrolment In Two Myeloma Studies Of Keytruda

Merck & Co., Inc. (NYSE:MRK) announced that it is pausing two late-stage studies evaluating its anti-PD-1 therapy, Keytruda, as a combination therapy for the treatment of multiple melanoma, a form of blood cancer. Shares were down more than 1% in after-hours trading.

Merck’s shares are up 9.2% year to date, comparing unfavorably with an increase of 10.8% witnessed by the Zacks classified Large-Cap Pharma industry.

The decision to stop new enrollment in the KEYNOTE-183 and KEYNOTE-185 phase III studies was taken at the recommendation of an external Data Monitoring Committee. The break in enrollment is meant to allow investigation of death of patients taking Keytruda. However, patients presently enrolled in the two studies would continue to receive the treatment.

While the KEYNOTE-183 study was evaluating a combination of Keytruda, Celgene Corporation’s (NASDAQ:CELG) Pomylast and dexamethasone, KEYNOTE-185 was studying a combination of Keytruda, Celgene’s Revlimid and dexamethasone

Presently, Keytruda is marketed in the U.S. and EU for the treatment of previously untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express high levels of PD-L1 and previously treated metastatic NSCLC in patients whose tumors express PD-L1, as well as advanced melanoma. In the U.S., it is also approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).

However, in the last couple of months, there were a series of regulatory approvals for the label expansion of Keytruda that should drive sales going forward. Keytruda brought in sales of $584 million in first-quarter 2017, up 20.9% sequentially and 134.5% year over year.

Last month, Keytruda was approved for the first- as well as second-line treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

The drug gained FDA approval last month for use in adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This makes Keytruda the first cancer therapy approved for use based on a biomarker regardless of tumor type.

Also, last month, the FDA granted accelerated approval to Keytruda for use in combination with Eli Lilly & Company’s (NYSE:LLY) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo), a commonly used chemo regimen, for the first-line treatment of metastatic NSCLC, irrespective of PD-L1 expression. Note that this is the first FDA approval for Keytruda as a combination therapy.

In Mar/Apr 2017, Keytruda received FDA and EU approval for refractory classical Hodgkin lymphoma (cHL) - the first Keytruda approval for hematologic malignancy indication.

Keytruda is continuously growing and expanding into new indications and markets globally and is considered to be one of Merck’s key growth drivers. Especially, its sales received a boost with the approval in the first-line lung cancer setting. With the recent label expansions, sales should pick up further in the upcoming quarters.

Meanwhile, Keytruda is being studied for more than 30 types of cancer in 500 trials. Almost 50% of these trials are in combination with other cancer drugs. Merck is collaborating with several companies including Amgen, Inc. (NASDAQ:AMGN) , Incyte, Glaxo and Pfizer (NYSE:PFE) separately for the evaluation of Keytruda in combination with other regimens.

Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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