Ganymeds IMAB362 Shows Strong Evidence of Single-Agent Activity in Phase IIa Trial in Gastroesophageal Cancer
Ganymed Pharmaceuticals AG has announced that its Ideal Monoclonal Antibody IMAB362 demonstrated significant safety and therapeutic benefits in a Phase IIa trial in gastroesophageal cancer (GEC). The trial involved 54 patients who had exhausted all other therapeutic options.
“This study establishes IMAB362’s high potential as novel treatment for patients with advanced gastroesophageal cancers,” commented Professor Martin Schuler, West German Cancer Center, Essen, who coordinated the study. “The clinical activity seen in this heavily pretreated study population is very promising for an antibody monotherapy.”
In the trial, patients with CLDN18.2-positive, metastatic, refractory or recurrent advanced GEC (NCT01197885) received 600 mg/m2 IMAB362 as a monotherapy every 2 weeks for five cycles. Final analyses indicate that partial response and stabilization of disease was achieved following IMAB362 treatment. A per protocol set of 21 patients showed a Disease Control Rate of 48%: of these patients, 19% underwent partial remission and 29% achieved stable disease state according to the Response Evaluation Criteria In Solid Tumors (RECIST).
The median Progression Free Survival (PFS) was 102 days (95% CI), ranging from 70 to 146 days. Patients with clinical benefits had a median PFS of 262 days as compared to a median PFS of 70 days for patients with disease progression. Nine patients continued treatment beyond five cycles due to clinical benefit and one patient has been benefiting from treatment for more than 16 months.
IMAB362 was safe and well tolerated during the study with nausea and vomiting being the most frequent drug related adverse event.
“I find it exciting that even as single agent, IMAB362 brought therapeutic benefits to patients to whom we have no other therapeutic options to offer,” said Professor Emeritus Christoph Huber, Co-founder and Supervisory Board member of Ganymed. “We are looking forward to seeing the results of the ongoing randomized Phase IIb study that includes 210 patients with gastroesophageal cancer receiving IMAB362 as first-line therapy in combination with chemotherapy. Based on preclinical data a synergistic effect of adding IMAB362 to best standard care is expected.”
Related News
-
News CPHI Frankfurt 2022: Innovator Interview – DSM Biomedical
At CPHI Frankfurt we spoke to Anne-Cecile Bayne, Global Science & Innovation Lead Pharma and Medical Nutrition, and Marc Hendriks, Vice President Strategy & Business Development, on their expertise in nitrosamines and business strategy at DSM Biomedica... -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled. -
News Magic mushrooms could be used to treat mental health conditions
A compound found in magic mushrooms, psilocybin, could be used to treat mental health conditions and help patients suffering with severe depression, as shown by the results of the largest study of its kind to date. -
News UK-based partnership to launch DETERMINE study into rare cancer research
UK-based CRO Quanticate is set to partner with Cancer Research UK for the launch of the DETERMINE study focused on testing a range of existing and approved drugs and therapies on rare cancers. -
News FDA approves Thermo Fisher blood tests for wheat and sesame allergies
Both tests have been approved by the US regulator for in vitro diagnostic use -
News QIAGEN launches world’s first syndromic test for monkeypox
The test can distinguish between monkeypox and other diseases that cause similar symptoms. -
News Monkeypox Update: Vaccine shortage, sewage surveillance and global testing
As concern over the monkeypox outbreak continues to rise, we take a look at major developments from the first week of August. -
News CPHI Podcast Series: The importance of novel excipients for innovative drug development
The latest episode in the CPHI Podcast Series dives into the world of novel excipients and explores their importance for innovative drug development.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance