Merck Receives Breakthrough Therapy Designation for Lung Cancer Drug, Share Price Rises 4.98%

Merck's ifinatamab deruxtecan has gained Breakthrough Therapy Designation for lung cancer treatment, leading to a 4.98% share price increase last month. The company's commitment to advancing its portfolio in oncology and cardiovascular diseases is positive, coinciding with a broadly positive market context. Merck's activities and market sentiment may have jointly influenced the stock's upward movement.

Merck's (NYSE: MRK) ifinatamab deruxtecan, a B7-H3 directed antibody drug conjugate (ADC) for the treatment of extensive-stage small cell lung cancer (ES-SCLC), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation, granted on August 2025, has been recognized for its potential to significantly improve patient outcomes [1].

The news of the Breakthrough Therapy Designation led to a 4.98% increase in Merck's share price last month, reflecting investor confidence in the company's commitment to advancing its oncology portfolio. The designation is based on the results of the IDeate-Lung01 Phase 2 trial, which demonstrated clinically meaningful response rates in patients with previously treated ES-SCLC. The trial showed an objective response rate (ORR) of 48.2% (95% CI: 39.6–56.9) and a disease control rate (DCR) of 87.6% (95% CI: 80.9–92.6) [1].

Merck's focus on innovative treatments for lung cancer aligns with broader market trends and investor sentiment. The company's activities in oncology and cardiovascular diseases have been well-received, contributing to a positive market context. This positive market sentiment, coupled with Merck's strategic advancements, has likely influenced the stock's upward movement.

The company's collaboration with Daiichi Sankyo (TSE: 4568) on ifinatamab deruxtecan underscores Merck's commitment to partnerships that drive innovation. The trial results and the Breakthrough Therapy Designation are promising steps towards providing new treatment options for patients with ES-SCLC, a disease with a low five-year survival rate [1].

References:
[1] https://www.merck.com/news/ifinatamab-deruxtecan-demonstrated-clinically-meaningful-response-rates-in-patients-with-extensive-stage-small-cell-lung-cancer-in-ideate-lung01-phase-2-trial/