January 2nd Week, 2026 Regulatory Events 🎯 Summit Therapeutics, Inc. has submitted a biologics license application to the US FDA seeking approval for Akeso Biopharma & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC. (Ref 1) ❓ What are the launch timeline estimates for the regimen in this indication? Special Designations ⭐ The US FDA granted the regenera

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)

February 2nd Week, 2025 📝 BMS’ Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) met primary endpoint of ORR and key secondary endpoint of CRR in marginal zone lymphoma (MZL) cohort. Detailed results will be presented at an upcoming conference (Ref 1, 2) ❓ What are the current benchmarks in MZL? 📝 Imugene’s Azer-cel (an allogeneic, anti-CD19 CAR-T) + low dose IL-2 elicited two additional complete responses resulting in a CRR o

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive recommendations in the Oncology space (Ref 1): ⭐ New Therapies: 👉 AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (TROP2-directed ADC) for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer (post-endocrine therapy + chemo) 👉 Pfizer, Zai Lab, and Genmab's tisotumab vedotin (tissue factor-di