.png)
Oncology Updates - Key Oncology News
- Oncofocus Team
- Jun 23
- 2 min read
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)
❓ What are the key differentiators for the combination that would allow it to capture a noteworthy market share?
🎯 Lepu Biopharma Co., Ltd withdrew its earlier submission and resubmitted the NDA for MRG003 (anti-EGFR ADC) with supplemental information to the NMPA, thus possibly delaying MRG003’s approval in China for the Tx of R/M nasopharyngeal cancer. (Ref 3)
❓ Based on the resubmission of the NDA, what are the expected changes in approval timelines of MRG003?
Clinical Events
🔬 In the Phase 3 DESTINY-Gastric04 trial, AstraZeneca & Daiichi Sankyo's trastuzumab deruxtecan (anti-HER2 ADC) demonstrated significant OS benefit vs ramucirumab + paclitaxel in second-line, HER2+ve unresectable/metastatic gastric/GEJ cancer. (Ref 4)
❓ With the OS benefit, will trastuzumab deruxtecan become the SOC or are there any shortcomings that could hinder its future market uptake?
🔬 In the Phase 3 MATTERHORN trial, AstraZeneca’s durvalumab (anti-PD-L1) + FLOT achieved a significant EFS benefit vs placebo + FLOT as a perioperative Tx for resectable, stages II-IVA gastric/GEJ cancers. (Ref 5)
❓ What are the current benchmarks in the perioperative setting of gastric/GEJ cancers?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
Comments