Merck & Co., Inc. (MRK - Free Report) is stealing the limelight at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. After presenting “practice changing” lung cancer data on its PD-L1 inhibitor, Keytruda, the drug giant presented encouraging data from studies evaluating the drug in advanced melanoma and small cell lung cancer (SCLC) patients.
Shares of Merck were up 2.4% on Monday in response to the positive news. This year so far, Merck’s shares have outperformed the industry. Its shares have risen 10.2% in the period against the industry’s decline of 4.5%.
Four and five years follow-up data presented from two pivotal advanced melanoma studies showed that treatment with Keytruda led to long-term survival benefit.
A new analysis of four-year data from the phase III KEYNOTE-006 study showed that 86% of the advanced melanoma patients remained progression free, 20 months after completing two years of treatment with Keytruda.
Five-year data from the melanoma cohort of the phase Ib KEYNOTE-001 study demonstrated significant survival benefits in advanced melanoma patients. The five-year OS rate, a secondary endpoint for the study, was 34% in all patients and 41% in previously untreated metastatic melanoma patients.
Interim data from a cohort of a phase II study, KEYNOTE-158, evaluating Keytruda as a monotherapy in patients with previously treated advanced small cell lung cancer (SCLC) demonstrated encouraging response rates in the overall population of SCLC patients as well as in patients whose tumors express PD-L1. In the overall population of SCLC patients, overall response rate (ORR – primary endpoint) was 18.7%, while in patients whose tumors expressed PD-L1, ORR was 35.7%.
Keytruda is being evaluated in combination with chemotherapy as a first-line treatment in patients with extensive stage small cell lung cancer in another phase III study, KEYNOTE-604.
Earlier at ASCO, Merck presented data from two pivotal lung cancer trials — KEYNOTE-042 study evaluating Keytruda monotherapy in newly-diagnosed lung cancer patients and KEYNOTE- 407 study evaluating Keytruda in combination with chemotherapy in difficult-to treat squamous non-small cell lung cancer (NSCLC). Both the studies showed that treatment with Keytruda led to improved survival, further cementing Merck’s position in the lung cancer market, which is the most lucrative oncology sector.
Meanwhile, Keytruda also demonstrated encouraging ORR in studies evaluating the Lenvima/Keytruda combination in four different tumor types and Keytruda monotherapy for the first-line treatment of advanced clear cell RCC.
Keytruda holds a dominant position in lung cancer as it is the only anti-PD-1 approved in first-line setting for certain lung cancer patients both as a monotherapy as well as a combination therapy with Eli Lilly’s (LLY - Free Report) cancer drug, Alimta (pemetrexed) and carboplatin (pem/carbo). In fact, Keytruda sales are gaining particularly from strong momentum in the first-line lung cancer indication.
Meanwhile, Keytruda is being evaluated in several lung cancer studies across multiple settings and stages of the disease, both as a monotherapy as well as a combination therapy.
Keytruda is being studied for more than 30 types of cancer in more than 700 studies, including in excess of 400 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
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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