Daiichi Sankyo and Merck Advance Novel ADC Combo in Tough-to-Treat Lung Cancer

Daiichi Sankyo Company (DSKYF) announced an update on their ongoing clinical study.

Daiichi Sankyo and Merck Launch New Lung Cancer Study With Novel Drug Combo

Study Overview: The trial, officially titled “A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer,” is designed to test new drug combinations for people with extensive-stage small cell lung cancer, a fast-growing form of lung cancer that has spread widely. The main goals are to see if these new regimens are safe, how well patients tolerate them, and whether the cancer shrinks or disappears. For investors, this is an early but important effort to expand Daiichi Sankyo’s antibody-drug conjugate (ADC) and Merck’s immunotherapy portfolios into a tough lung cancer segment.

Intervention/Treatment: The study tests two key experimental drugs: gocatamig (MK-6070), a targeted immune-activating treatment, and ifinatamab deruxtecan (I-DXd, MK-2400), an ADC that delivers a cancer-killing payload directly to tumor cells. These study drugs are given alone in combination and also alongside standard chemotherapy and immunotherapy, including atezolizumab, plus usual rescue medicines to manage side effects. The aim is to improve outcomes versus current standard treatment while keeping side effects manageable.

Study Design: This is an interventional Phase 1b/2 study with randomized patient assignment across several treatment arms. Patients are split into parallel groups that receive different drug combinations, including both the new regimens and a standard-of-care control arm with carboplatin, etoposide, and atezolizumab. The trial is open-label, meaning doctors and patients know which treatment they get; the focus is on treatment benefit and safety, not on placebo comparison. The primary purpose is to treat cancer and find the most promising dosing and combinations to move forward.

Study Timeline: The study was first submitted on November 10, 2025, indicating recent regulatory engagement and the start of operational setup. The trial status is “not yet recruiting,” so patient enrollment has not started but is expected soon. The latest update was submitted on December 29, 2025, confirming that the protocol and operational details are being actively refreshed. Primary completion and full completion dates are not yet listed, which is typical for a complex early-stage oncology program, but investors should assume several years before mature efficacy data are available.

Market Implications: For Daiichi Sankyo (DSKYF), this trial reinforces its strategic push in ADCs beyond breast and gastric cancers into small cell lung cancer, a space with high unmet need and limited innovation. Partner Merck gains another shot on goal in lung cancer, complementing its broader immunotherapy franchise. While near-term financial impact is minimal, confirmation that this study is advancing can support investor confidence in Daiichi Sankyo’s ADC platform and long-term revenue pipeline. The inclusion of an active control arm using standard chemo-immunotherapy sets a clear bar against existing treatments from players such as Roche and others in lung cancer. Any future positive safety and response data could strengthen Daiichi Sankyo’s competitive position in oncology and may support multiple expansion, though investors should remember the high attrition rate in early-stage oncology trials and view this as a long-duration, high-risk/high-reward asset. The study is currently ongoing in setup, with further operational and outcome details available on the ClinicalTrials portal.

To learn more about DSKYF’s potential, visit the Daiichi Sankyo Company drug pipeline page.