Merck & Co., Inc. (MRK - Free Report) announced positive data from several oncology studies, which will be presented in an oral abstract session of the virtual scientific program of the annual meeting of the American Society of Clinical Oncology (“ASCO”). The ASCO meeting is scheduled to be held at the end of this month. The presentation will include data from studies evaluating the company’s blockbuster anti-PD-1 therapy, Keytruda, in several cancer indications namely relapsed or refractory (r/r) classical Hodgkin lymphoma (cHL), metastatic triple-negative breast cancer (mTNBC) and non-small cell lung cancer (“NSCLC”).
Merck’s shares have declined 12% so far this year compared with the industry’s decrease of 1.5%.
The phase III KEYNOTE-355 study is evaluating Keytruda in combination with chemotherapy as first-line treatment for mTNBC patients. Data showed that treatment with Keytruda-chemo regimen achieved statistically significant and clinically meaningful improvement in progression-free survival ("PFS") compared to chemotherapy alone in patients whose tumors expressed PD-L1 with combined positive score (CPS) ≥10. The combo regimen reduced the risk of disease progression or death by 35% and improved PFS to a median of 9.7 months compared to 5.6 months compared to chemotherapy alone.
Data from another phase III head-to-head study — KEYNOTE-204 — showed that treatment of r/r cHL patients with Keytruda monotherapy achieved statistically significant and clinically meaningful improvement in PFS compared to current standard of care, Seattle Genetics, Inc.’s (SGEN - Free Report) Adectris (brentuximab vedotin). Please note that Keytruda is already approved for r/r cHL under accelerated pathway. The data showed that Keytruda monotherapy significantly reduced the risk of disease progression or death by 35% and showed a median PFS of 13.2 months compared with 8.3 months for Adectris. Data from KEYNOTE-204 study will support continued approval for Keytruda in r/r cHL.
Merck also announced data from the phase II KEYNOTE-799 evaluting Keytruda in combination with chemoradiation therapy for treating previously-untreated patients with advanced NSCLC. The regimen achieved an objective response rate ("ORR") of 67% in patients with squamous and nonsquamous NSCLC and ORR of 56.6% in nonsquamous NSCLC patients. Moreover, final follow-up data from phase III KEYNOTE-189 study showed that 45.7% of patients with metastatic nonsquamous NSCLC treated with Keytruda in combination with chemotherapy remained alive compared to 22.7% for chemotherapy alone.
We note that Keytruda has significantly boosted Merck’s top line,recording strong growth in the past few years. The drug generated $3.3 billion in the first quarter of 2020 and $11.1 billion in 2019, representing a year over year growth of almost 45% and 55%, respectively. Potential approval for label expansion of Keytruda based on the positive data readouts will further boost the drug’s sales and maintain its lead in the immuno-oncology market where it faces competition from Bristol-Myers’ (BMY - Free Report) Opdivo, Roche’s (RHHBY - Free Report) Tecentriq and AstraZeneca’s Tagrisso.
Apart from Keytruda, Merck also announced data from a phase II study evaluating its hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482 in patients with von Hippel-Lindau disease-associated clear cell renal cell carcinoma (ccRCC). Data from the study showed that treatment with the candidate achieved a confirmed ORR of 27.9%. Based on the data from this study, the company will decide on further evaluation of the candidate in this indication.
Please note that Von Hippel-Lindau disease is a rare hereditary condition, which affects multiple organs and puts patients at risk ofseveral cancers, including renal cell carcinoma. Cancer is one of the main causes of death for people with von Hippel-Lindau disease.
Merck currently carries 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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