Merck & Co., Inc.’s MRK PD-L1 inhibitor, Keytruda ruled at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago as the drug giant presented additional data from two pivotal lung cancer studies on the drug.
Merck presented additional data from the pivotal KEYNOTE-042 study in patients with locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1 protein levels of 1 percent or greater (TPS of ≥1 percent).
In April, Merck had said that in such patients, Keytruda led to a significant survival benefit compared with platinum-based chemotherapy. With the latest release, the company said that in patients with TPS of ≥1 percent, median overall survival (OS) was 16.7 months in the Keytruda arm versus 12.1 months in chemotherapy arm. In the PD-L1 TPS ≥50 percent patient population, median OS was 20 months while that in patients with TPS of ≥20 percent was 17.7 months versus 12.2 months and 13 months, respectively for chemotherapy alone.
Also, Merck said the risk of progression or death or progression-free survival (PFS) — the secondary endpoint — was 19% in the PD-L1 TPS ≥50 percent population at the time of interim analysis, which was not statistically significant.
Notably, Keytruda monotherapy is already marketed for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50 percent or greater (TPS of ≥50 percent) based on data from the KEYNOTE-024 study.
If the OS data from KEYNOTE-042 study are approved to be included in Keytruda’s label, the drug can be prescribed to treat an expanded lung cancer patient population, further reinforcing its position in the lung cancer market. Later in the year, Merck will file regulatory application to get the OS data from the study included in the label of Keytruda.
Merck also announced data from a second interim analysis of a pivotallung cancer study on Keytruda — phase III KEYNOTE- 407 study — which evaluated Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel (chemotherapy) for the first-line treatment of metastatic squamous NSCLC. The data from the study showed that the combination of Keytruda plus chemotherapy led to significant improvement in both OS and PFS regardless of PD-L1 expression. The risk of death (OS) was reduced by 36% compared to chemotherapy alone. The median OS was 15.9 months in the Keytruda combination group versus 11.3 months in the chemotherapy arm. The PFS improvement was nearly half for patients in the Keytruda combination group compared with chemotherapy alone. The median PFS was 6.4 months in the Keytruda combination group versus 4.1 months in the chemotherapy arm.
A regulatory application to include data from this study was submitted to the FDA in May. At the same time, the company had presented data from the first interim analysis of the KEYNOTE- 407 study. It said that the study met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants. At ASCO, the company said that ORR was 57.9% in the Keytruda arm compared to 38.4% for chemotherapy alone
Metastatic squamous NSCLC is a difficult-to-treat population, which accounts for about 30% of lung cancer cases. If the Keytruda combination is approved to treat this difficult-to-treat population, lung cancer sales of the drug should improve further.
This year so far, Merck’s shares have outperformed the industry. Its shares have risen 7.6% in the period against the industry’s decline of 4.5%.
Keytruda is the second largest product in Merck’s portfolio. It is marketed for many types of cancer and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma, gastric cancer, bladder cancer and microsatellite instability-high (MSI-H) or mismatch repair deficient cancer.
The treatment fetched sales of $3.8 billion in 2017, up almost 172% year over year. This upside is driven by the global launch of new indications, which further bolstered demand. Keytruda sales are gaining, particularly from strong momentum in the first-line lung cancer indication. In fact, Keytruda is the only anti-PD-1 approved in the first-line setting for certain lung cancer patients both as a monotherapy as well as a combination therapy with Eli Lilly’s LLY cancer drug, Alimta (pemetrexed) and carboplatin (pem/carbo).
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.
At ASCO, Merck also presented data from several combination studies of tyrosinekinase inhibitor, Lenvimaplus Keytruda at ASCO.
The studies evaluating the Lenvima/Keytruda combination in four different tumor types — unresectable hepatocellular carcinoma (HCC), squamous cell carcinoma of the head and neck (SCCHN), advanced renal cell carcinoma (RCC), and advanced endometrial carcinoma (EC) — demonstrated encouraging ORR as well as safety profile of this cancer combination.
We remind investors that in March, Merck formed a deal with Japan’s Eisai to co-develop and commercialize Lenvima, both as a monotherapy as well as in combination with Keytruda for several types of cancer.
At ASCO, Merck also presented interim data from a mid-stage study (KEYNOTE-427) evaluating Keytruda monotherapy for the first-line treatment of advanced clear cell RCC. The data showed that in the Keytruda arm, the ORR — the primary endpoint — was 38.2%. Meanwhile, in a sub-group of patients whose tumors expressed PD-L1, the ORR was 50%.
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, Incyte, Glaxo GSK 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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