{"id":866184,"date":"2025-07-02T11:18:08","date_gmt":"2025-07-02T15:18:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-presents-positive-givastomig-phase-1b-dose-escalation-data-in-combination-with-immunochemotherapy-in-patients-with-1l-gastric-cancers-at-esmo-gi-2025\/"},"modified":"2025-07-02T11:18:08","modified_gmt":"2025-07-02T15:18:08","slug":"i-mab-presents-positive-givastomig-phase-1b-dose-escalation-data-in-combination-with-immunochemotherapy-in-patients-with-1l-gastric-cancers-at-esmo-gi-2025","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-presents-positive-givastomig-phase-1b-dose-escalation-data-in-combination-with-immunochemotherapy-in-patients-with-1l-gastric-cancers-at-esmo-gi-2025\/","title":{"rendered":"I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025"},"content":{"rendered":"
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\n Data show confirmed ORR of 83% (10\/12) at doses selected for ongoing expansion study<\/em>\n <\/p>\n

\n Median follow-up of 9.0 months as of the updated data cutoff <\/em>\n <\/p>\n

\n Responses observed in patients with low PD-L1 and\/or CLDN18.2 expression<\/em>\n <\/p>\n

\n Company to host investor event on Tuesday, July 8<\/em>
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ROCKVILLE, Md., July 02, 2025 (GLOBE NEWSWIRE) — I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025)<\/em> in Barcelona (abstract #388MO). <\/em>Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. I-Mab plans to host a virtual investor event on Tuesday, July 8th<\/sup> (register here<\/a>) to review these data.<\/p>\n

The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12\/17), and 83% (10\/12) at doses selected for the ongoing dose expansion study (8 mg\/kg and 12 mg\/kg). Responses occurred in tumors with low levels of PD-L1 expression and\/or Claudin 18.2 (CLDN18.2) expression, with favorable overall tolerability. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. The data are based on the results of the dose escalation part of a Phase 1b study evaluating the givastomig combination as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (\u22651+ IHC staining intensity in \u22651% of tumor cells). The primary endpoint is safety. The study enrolled only patients in the U.S.<\/p>\n

\u201cThe positive Phase 1b combination data presented at ESMO GI bolster our confidence in givastomig\u2019s potential to be a best-in-class Claudin 18.2 directed therapy. Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time, supported by consistent pharmacokinetic data and soluble 4-1BB induction,\u201d said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.<\/strong> \u201cIn addition, we are optimistic about the results from the 8 mg\/kg and 12 mg\/kg doses. These doses showed an ORR of 83%, with consistent responses across PD-L1 and Claudin 18.2 expression levels, and a favorable overall safety profile. These data further our conviction in the ongoing Phase 1b dose expansion study. We believe givastomig has broad potential in a number of gastric cancer settings and look forward to continued advancement of the program.\u201d<\/p>\n

\u201cI am encouraged by the response rates, as well as the deepening of responses over time, demonstrated by the givastomig combination regimen in the Phase 1b dose escalation study that we presented today at ESMO GI. Despite approved therapies, targeted treatment options for gastric cancers continue to be limited. While the data are early, givastomig combination therapy demonstrates a high response rate across Claudin 18.2 and PD-L1 expression levels,\u201d said\u00a0Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital<\/strong>. \u201cIn addition, I have been pleased to observe that givastomig has a favorable overall tolerability profile with a low level of gastrointestinal side effects — especially important for patients with gastric cancer. I look forward to participating in the ongoing givastomig clinical development program, and hope we may be able to expand the population of patients who may benefit from Claudin 18.2 directed agents.\u201d<\/p>\n

\n Virtual Investor Event: <\/strong>
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Register (here<\/a>) for the Post-ESMO GI 2025 Investor Event to be held on Tuesday, July 8th<\/sup> at 2:00 PM EDT. A replay of the webinar will be accessible on the Events page of the I-Mab website for 90 days.<\/p>\n

\n Fireside Chat Event with Lucid Capital Markets to Recap the Presentation: <\/strong>
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Tune in (here<\/a>) for a fireside chat sponsored by Christopher Liu, PharmD, Managing Director at Lucid Capital Markets that will be accessible today at 2:00pm EDT on the Events page of the I-Mab website. A replay of the fireside chat will be available for 90 days.<\/p>\n

\n ESMO GI Presentation Details:<\/strong>
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A full copy of the ESMO GI presentation is available on the Publications and Presentations page of the I-Mab website here<\/a>.<\/p>\n

\n Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers <\/strong>\n <\/p>\n