AbbVie's Temab-A Wins Two FDA Breakthrough Therapy Tags in CRC and NSCLC

Baili Tianheng announced that the company recently received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration. The clinical trial of its self-developed, world-first bispecific antibody drug conjugate Yizekang, also known as luncoitab, in combination with radiotherapy for locally advanced unresectable head and neck squamous cell carcinoma and other solid tumors has been approved. To date, the drug has initiated more than 45 clinical trials in China and the United States, including 20 Phase III clinical studies, and 9 indications have been included in the breakthrough therapy designation list by the Center for Drug Evaluation.

AbbVie received two FDA Breakthrough Therapy Designations for its experimental cancer drug telisotuzumab adizutecan in colorectal cancer and non small cell lung cancer. The designations apply to biomarker defined patient groups in those two large solid tumor indications, and they mark the first Breakthrough Therapy status for telisotuzumab adizutecan, which sits in AbbVie's antibody drug conjugate pipeline. Colorectal cancer and non small cell lung cancer together affect more than four million people worldwide each year, and the focus on biomarker defined groups, including c Met protein expressing NSCLC, points to narrower patient pools but potentially higher value treatment settings. The designations support the view that AbbVie needs its pipeline to replace aging blockbusters such as Humira and Imbruvica, with telisotuzumab adizutecan complementing oncology assets like etentamig. The next signpost is how the ongoing Phase 3 and Phase 2/3 telisotuzumab adizutecan studies progress and when AbbVie moves toward regulatory filings in colorectal cancer and non small cell lung cancer, building on the first in human M21 404 data.

Akeso, Inc. announced that the first patient has been dosed in a Phase III clinical study evaluating cadonilimab, its first-in-class PD-1/CTLA-4 bispecific antibody, as monotherapy in the neoadjuvant/adjuvant perioperative treatment of resectable microsatellite instability-high or mismatch repair-deficient colon cancer. The trial, designated COMPASSION-40/AK104-313, marks a significant new indication for cadonilimab beyond gastric, lung, and cervical cancers, and is the 13th Phase III or registrational study of the therapy conducted globally. Colorectal cancer is among the malignancies with the highest incidence and mortality worldwide, and patients with MSI-H/dMMR colon cancer derive limited benefit from conventional perioperative chemotherapy, with pathological response rates of only approximately 7%. No immunotherapy has yet been approved anywhere for the perioperative treatment of localized MSI-H/dMMR colon cancer. Supporting evidence comes from a prior Phase II study of cadonilimab monotherapy as neoadjuvant treatment in MSI-H/dMMR colorectal cancer, where data presented at the 2024 ESMO Immuno-Oncology Congress showed a pathological complete response rate of 84.6% and a major pathological response rate of 100% among patients who proceeded to surgery, with a manageable safety profile.

Shares of Moderna and Novavax rose today after The New York Times reported that the US National Institutes of Health, or NIH, plans to launch a public-private partnership to accelerate the development of personalized cancer vaccines. The vaccine project is expected to begin in December, focusing on pancreatic cancer, liver cancer, and colorectal cancer, as well as certain tumors in children. Previous trials have used mRNA technology to train the body's immune system to recognize and attack proteins specific to cancer cells. The positive reaction to the news was most evident for Moderna, which is developing personalized mRNA cancer vaccines together with Merck. Moderna's share price has soared more than 600% since the start of this year, making it the best-performing stock among the companies used to calculate the S&P 500 index.