This Week’s Biopharma News: ADCs, Biosimilars, and Microbiome Moves
Merck’s TROP2 ADC delivers a phase III win in endometrial cancer, as new golimumab biosimilars and an oral microbiome therapy move forward
Clinical Scorecard: This Week’s Biopharma News: ADCs, Biosimilars, and Microbiome Moves
At a Glance
Category Detail
Condition
Key Mechanisms Antibody-drug conjugates, microbiome co-therapy, anti-CD47 monoclonal antibodies
Target Population
Care Setting
Key Highlights
Sacituzumab tirumotecan met phase 3 endpoints in endometrial cancer. MB097 showed positive phase 1b results in advanced melanoma. Ligufalimab demonstrated a survival signal in phase 2 AML trial. Regeneron's LAG-3 combination failed to meet phase 3 melanoma endpoint. FDA approved first golimumab biosimilars.
Guideline-Based Recommendations
Diagnosis
Evaluate patients for advanced or recurrent cancer.
Management
Consider sacituzumab tirumotecan for endometrial cancer after prior therapies. Use MB097 in combination with pembrolizumab for melanoma patients with primary resistance.
Monitoring & Follow-up
Monitor for adverse events in patients receiving microbiome therapy.
Risks
Assess risks of elevated viscosity and aggregation in high-concentration monoclonal antibodies.
Patient & Prescribing Data
Patients with advanced or recurrent cancer, including those ineligible for intensive chemotherapy.
Combination therapies are being explored for improved outcomes in various cancers.
Clinical Best Practices
Utilize pregnancy registries for postapproval safety studies. Integrate protein engineering and real-time analytics in high-concentration mAb manufacturing.
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