Merck’s (MRK - Free Report) shares increased 2.59% on Apr 16 after it presented full data from the pivotal phase III KEYNOTE-189 study. Data from the same showed that Keytruda combined with Eli Lilly’s (LLY - Free Report) Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) significantly improved overall survival, thereby reducing the death risk by half (51%) compared with chemotherapy alone.
The study evaluated the combination therapy for first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression. The combo treatment showed progress in overall survival irrespective of PD-L1 expression including patients with tumors testing negative for PD-L1.
Meanwhile, a significant improvement in progression-free survival (PFS) was observed with decrease in death risk by 48% in the Keytruda combination arm compared with the chemotherapy arm. The median PFS was 8.8 months in the Keytruda arm compared with 4.9 months in the chemotherapy one. A PFS improvement was also observed in patients, whose tumors tested negative for PD-L1.
The results were presented at the annual meeting of the American Association for Cancer Research.
Notably in January this year, Merck had announced that the study met both its primary endpoints, PFS and OS as well.
Importantly, Keytruda is the first PD1 inhibitor in combination to show OS in patients with NSCLC.
Last May, this combination therapy was granted an accelerated approval by the FDA for the aforementioned indication. The nod was based on tumor response rate and PFS data from the KEYNOTE-021 trial. Hence, the positive readouts from the KEYNOTE-189 confirmatory study will help the company gain a continued approval for the combo therapy, which should in turn support uptake and sales.
We remind investors that in the third quarter of 2017, Merck had mentioned that it is including the overall survival (OS) as a co-primary endpoint in the KEYNOTE-189 program, which could defer the readout from the study to 2019. It was then estimated that the evaluation would be completed by February 2019. However, the company released data from KEYNOTE-189 study a year earlier than expected in January 2018.
Merck’s shares have gained 6.2% so far this year versus the 2.7% decline of its industry.
Concurrently, Bristol-Myers (BMY - Free Report) also reported data from a phase III study on its blockbuster drug Opdivo for NSCLC. However, Merck’s Keytruda combination demonstrated better overall survival compared with Opdivo.
Zacks Rank & Key Pick
Merck carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Ligand Pharmaceuticals Incorporated (LGND - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved up from $3.78 to $4.40 for 2018 and from $4.75 to $5.32 for 2019 in the last 60 days. The company delivered a positive surprise in three of the trailing four quarters with an average beat of 24.88%. Share price of the company has soared 60.7% over a year.
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