Merck & Co., Inc. (MRK - Free Report) presented encouraging five-year survival data on its PD-L1 inhibitor, Keytruda in patients with advanced non-small cell lung cancer (NSCLC) at the annual meeting of American Society of Clinical Oncology (ASCO).
Data from the phase Ib KEYNOTE-001 study (n=550) showed that five-year overall survival (OS) rates for Keytruda were 23.2% in treatment-naïve patients and 15.5% in previously treated lung cancer patients. In lung cancer patients whose tumors express PD-L1 protein levels of 50 percent or greater (TPS of ≥50 percent), the five-year OS rate was 29.6% in treatment-naïve patients and 25% in previously treated patients.
Historically, the five-year survival rate in advanced lung cancer patients in the United States has been around 5%. Keytruda’s five-year survival rates thus represent a huge improvement over these historical rates.
At ASCO, Merck also presented follow up lung cancer data from the KEYNOTE-189 study at ASCO. After a median follow-up of 18.7 months, an updated analysis of the OS endpoint showed that Keytruda in combination with Lilly’s (LLY - Free Report) Alimta (pemetrexed) and platinum chemotherapy reduced the risk of death by 44% compared with chemotherapy alone as a first-line treatment option for metastatic non-squamous NSCLC in patients with no EGFR or ALK genomic tumor aberrations.
The data also showed that the Keytruda+chemo arm led to 52% reduction in the risk of progression or death (progression-free survival) compared with chemotherapy alone Notably, data from the KEYNOTE-189 study is already included in Keytruda’s U.S. and EU label.
Merck also presented full data from the phase III KEYNOTE-062 study evaluating Keytruda as monotherapy and in combination with chemotherapy for the first-line treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. The data showed that a statistically significant improvement in overall survival was not reached for the Keytruda+chemo arm. Top-line data from the study were earlier announced in April.
Merck’s shares have performed well this year so far. Merck’s shares have risen 6.2% this year so far against the industry’s decrease of 2.5%.
Keytruda, Merck’s biggest product, is already approved for use in 15 cancer indications across 10 different tumor types in the United States.
Keytruda generated sales of $2.27 billion in the first quarter of 2019, up around 5.6% sequentially and 55% year over year. Sales were driven by the launch of indications globally. Keytruda sales are gaining particularly from strong momentum in first-line lung cancer indication both as monotherapy and with the rollout of the chemo combo in both non-squamous and squamous NSCLC.
The encouraging five-year survival rates, which represent the longest follow-up for Keytruda in lung cancer, further strengthens its position in the lung cancer market where it competes with Bristol Myers’ (BMY - Free Report) Opdivo, AstraZeneca’s Imfinzi, Roche’s Tecentriq and Pfizer’s Bavencio.
This year so far, Keytruda has gained several label expansion approvals. Keytruda was approved by the FDA as an adjuvant therapy for high-risk stage III melanoma and for five new cancer line extensions in Japan in the first quarter. In April, the FDA gave approval to Keytruda in combination with Pfizer’s (PFE - Free Report) Inlyta for the first-line treatment of advanced renal cell carcinoma (RCC) as well as for an expanded first-line lung cancer patient population. All these label expansion approvals should drive sales of Keytruda higher in the future quarters of 2019.
Several regulatory decisions for new indications in the United States as well as in Europe are pending in 2019, which, if approved, can further boost sales of Keytruda. In June, FDA decisions are expected on regulatory applications looking for label expansion of Keytruda for previously treated advanced small-cell lung cancer (SCLC) and first-line treatment of recurrent or metastatic HNSCC.
Merck currently 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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