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Innovent has reported the P-III (G-HOPE-001) of arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2 positive, locally advanced unresectable or metastatic G/GEJA who have received ≥2 prior therapies
Trial met its 1EP of improved PFS in the interim analysis & showed a favorable safety profile; data to be published in future…
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Eisai & Henlius have entered into an exclusive commercialization & co-exclusive development & manufacturing license agreement for serplulimab (Hetronifly in the EU) in Japan
As per the deal, Eisai will obtain exclusive rights to commercialize serplulimab in Japan in exchange for $75M upfront, ~$80.01M in regulatory milestones, ~$233.3M in sales milestones, with double-digit royalties…
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The Chinese NMPA has accepted NDA & granted priority review to savolitinib for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments
NDA was supported by the P-II trial of savolitinib in gastric cancer pts with MET amplification in China, which met its 1EP of improved ORR by…
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US FDA has granted Orphan Drug Designation (ODD) to SN BioScience’s SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer
SNB-101 is currently under P-Ib/II development for small cell lung cancer and is being evaluated across multiple solid tumor indications in Korea, Europe and US
SNB-101 is a polymer nanoparticle formulation of…
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Evorpacept emerges as the only CD47-blocking therapy with strong clinical activity and a highly manageable safety profile, thanks to its unique inactive Fc design that enables targeted tumor destruction while sparing healthy cells
Updated ASPEN-06 data highlights CD47 overexpression as a powerful predictive biomarker, showing dramatic improvements in ORR, DOR, PFS, and OS for patients with…
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Ono Pharmaceutical has reported the P-II (ONO-4578-08) trial findings of ONO-4578 (EP4 antagonist) regimen for previously untreated, HER2-negative unresectable advanced or recurrent G/GEJ cancer
ONO-4578-08 assessed ONO-4578 (40mg, QD, PO) + Opdivo (360mg, Q3W) & CT (S-1 + Oxa or CapOx) vs PBO + Opdivo & CT in G/GEJ cancer pts across Japan, South Korea…
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Akeso has enrolled & dosed its first patient with cadonilimab (PD-1/CTLA-4 BsAb) + CT in P-III (AK104-310/COMPASSION-33) trial for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma
The P-III (COMPASSION-33) trial in resectable G/GEJ adenocarcinoma pts is designed to improve radical resection rates, lower recurrence & metastasis risk, & improve patient outcomes
Additionally,…
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Evopoint Biosciences has granted Astellas exclusive license to develop & commercialize XNW27011 globally, excl. Mainland China, Hong Kong, Macao & Taiwan
As per the deal, Evopoint will receive $130M upfront as well as ~$70M as near-term payments in addition to ~$1.34B in development, regulatory & commercial milestones, with net sales-based royalties
XNW27011, an CLDN18.2-specific…
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HUTCHMED has completed pts enrollment in P-II trial assessing savolitinib for G/GEJ adenocarcinoma pts (n=64) with MET amplification to evaluate ORR per IRC (1EP) & 2EPs incl. PFS & AE incidence; HUTCHMED plans to file for potential NMPA’s Approval in late 2025
Interim analysis of the trial showed 45% cORR by IRC & 50% ORR in…
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The company will highlight data from P-I/II (CLINCH) trial of ATN-022 to treat advanced/metastatic gastric cancer in Australia & China at ASCO GI 2025 under the title, ‘Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)’
In the dose expansion phase (as of Nov 2024), 21 patients with CLDN18.2…

