Merck Launches Pivotal Phase III Trials for Four Novel Oncology Candidates Including TROP2 ADC MK-2870 and BTK Inhibitor Nemtabrutinib

Jan 06, 2024 09:09 CST Updated 09:09

MSD

Pharmaceutical R&D and Manufacturer

On January 5, MSD announced that four of its investigational drugs in the fields of hematologic malignancies and solid tumors have initiated multiple pivotal Phase III clinical trials. These include the LSD1 inhibitor Bomedemstat, the BTK inhibitor Nemtabrutinib, the TROP2 ADC MK-2870, and the CYP11A1 inhibitor MK-5684.

Bomedemstat is an oral lysine-specific demethylase 1 (LSD1) inhibitor currently under investigation in the Phase III MK-3543-006 study (NCT06079879). This study aims to evaluate its efficacy and safety compared to Best Available Therapy (BAT) in patients with hydroxyurea-resistant or intolerant essential thrombocythemia (ET). The study plans to enroll approximately 300 participants.

Nemtabrutinib is an oral, reversible, non-covalent Bruton's tyrosine kinase (BTK) inhibitor currently under investigation in the Phase III BELLWAVE-011 study (NCT06136559), which aims to evaluate its efficacy and safety compared to ibrutinib and acalabrutinib as a first-line treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The study plans to enroll approximately 1,200 participants.

MK-2870 is an antibody-drug conjugate (ADC) targeting trophoblast cell surface antigen 2 (TROP2) co-developed by MSD and Kelun Biotech. It is currently undergoing three pivotal Phase III clinical trials, including the MK-2870-004 study (NCT06074588), the MK-2870-007 study (NCT06170788), and the MK-2870-005 study (NCT06132958).

The MK-2870-004 study aims to evaluate the efficacy and safety of MK-2870 compared with chemotherapy (docetaxel or pemetrexed) in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer (with EGFR mutations or other genetic mutations), with approximately 556 participants planned for enrollment.
The MK-2870-007 study aims to evaluate the efficacy and safety of MK-2870 in combination with Keytruda versus Keytruda monotherapy as a first-line treatment for PD-L1 TPS ≥50% metastatic non-small cell lung cancer, with plans to enroll approximately 614 participants.
The MK-2870-005 study aims to evaluate the efficacy and safety of MK-2870 monotherapy compared to chemotherapy (doxorubicin + paclitaxel) in endometrial cancer patients who have received platinum-based chemotherapy and immunotherapy, with plans to recruit approximately 710 participants.

MK-5684 is a CYP11A1 inhibitor jointly developed by MSD and Orion. Two pivotal Phase III clinical trials have been initiated, including the OMAHA1 study (NCT06136624) and the OMAHA2a study (NCT06136650).

OMAHA1 Study Aims to Evaluate the Efficacy and Safety of MK-5684 in Combination with HRT Compared to Alternative NHA (Abiraterone or Enzalutamide) in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Next-Generation Hormonal Agents (NHA) and Taxane-Based Chemotherapy, Planning to Enroll Approximately 1200 Participants.
OMAHA2a Study Aims to Evaluate the Efficacy and Safety of MK-5684 in Combination with HRT in mCRPC Patients Who Have Progressed on or After NHA Treatment Compared to Alternative NHA, Planning to Enroll Approximately 1500 Participants.

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