Adlai Nortye’s study of oral EP4 antagonist shows encouraging clinical results in locally advanced rectal cancer

Researchers presented results from Adlai Nortye’s investigational, potentially first in class oral EP4 antagonist, two dose levels of AN0025 in combination with the standard of care for locally advanced rectal cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by MRI at ESMO.

Dr. Lars Birgerson, Chief Development Officer of Adlai Nortye said the company plans to move AN0025 plus chemoradiotherapy into a randomized confirmatory trial without delay.

The study brought encouraging preliminary clinical results, as it showed that AN0025 was well tolerated in combination with chemoradiation as well as to radiotherapy followed by consolidation chemotherapy.

Lead author Dr. Lucjan Wyrwicz, from Department of Oncology and Radiotherapy, M. Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland.  “There is a tremendous need for new treatment strategies in rectal cancer, especially in patients with high-risk of relapse enrolled in this study. With nearly 40% of patients not requiring surgery or achieving a complete pathological response in the post-surgical specimen in this study, AN0025 in combination with the standard pre-operative treatment warrants further development.  The excellent toxicity profile of this novel immunotherapy and potential combination with both conventionally fractionated radiochemotherapy or short course irradiation with consolidating chemotherapy make this strategy feasible worldwide.”

He added: “My patients are more and more often asking for organ preservation in rectal cancer and for many of them only a complete clinical response without any surgery is the desired outcome of treatment.”

Dr. Theodore S. Hong, from Dana-Farber/Harvard Cancer Center, Professor of Radiation Oncology, Harvard Medical School (among other, said: “Given the unique mechanism of action and strong preclinical rationale, combined with the excellent tolerability and encouraging results, further study of AN0025 in preoperative therapy for rectal cancer are warranted.  One question remains if there is a benefit to continuous exposure with AN0025 with FOLFOX followed by chemoradiation with AN0025 in a total neoadjuvant therapy (TNT) paradigm. Further evaluation in randomized trials is eagerly awaited.” Dr. Hong was also an investigator in the study.

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