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GSK's Jemperli Shows 76% Complete Response Rate in Rectal Cancer Trial
GSK Plc announced that its immunotherapy Jemperli demonstrated a 76% complete response rate in a Phase II trial for patients with a specific subset of locally advanced rectal cancer. The results, presented on Monday, suggest a potential new treatment paradigm that could allow patients to avoid traditional surgery, radiation, and chemotherapy.
AZUR-1 Trial Details
The data comes from an exploratory analysis of the AZUR-1 study, which evaluated Jemperli as a standalone treatment. The trial enrolled adults with stage II and III rectal cancer characterized by a mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) genetic trait, which impairs DNA repair in tumors.
In the analysis of 144 evaluable patients, 110 (76%) achieved a complete response. This included 68% of patients who had a clinical complete response lasting at least 12 months without undergoing surgery. GSK also reported that no recurrences have been observed among responders after a median follow-up of more than two years.
Clinical Significance and Market Context
AdThe findings point to a significant shift in how this type of cancer could be managed. "For some patients, avoiding chemotherapy, radiation and surgery may now be possible,” said Hesham Abdullah, GSK’s global head of oncology R&D. The company confirmed that this data supported the recent U.S. approval of Jemperli for this use.
Regarding the drug's safety profile in the trial, serious adverse reactions occurred in 20% of patients, with 3% discontinuing treatment due to side effects. The full dataset will be presented at the European Society for Medical Oncology (ESMO) congress in Madrid.
Broader Oncology Pipeline Update
In a separate announcement, GSK also reported positive Phase I results for its experimental antibody-drug conjugate, mocertatug rezetecan (Mo-Rez), in platinum-resistant ovarian cancer. The BEHOLD-1 trial showed a confirmed response rate of 62% and a median progression-free survival of 11.1 months at the dose level selected for Phase III studies. GSK, which acquired rights to Mo-Rez from Hansoh Pharma, has five pivotal Phase III trials for the asset underway.
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