Himalaya Therapeutics has given an interim topline data update from its phase 2 study of HTBA3011 (mecbotamab vedotin) in non-small cell lung cancer (NSCLC) and certain sarcomas.
In August, Himalaya’s collaboration partner, BioAtla publicly announced operational updates on the ongoing global clinical trials for HTBA3011 in patients with AXL-positive NSCLC who have previously failed PD-1/L1, EGFR, or ALK inhibitor therapy.
These trials included patients from Greater China, where Himalaya Therapeutics has regional rights for the product candidate, and where lung cancer is both the most frequent cancer, and the cancer with the highest mortality rate.
Of nine evaluable patients to date, two partial responses (PR) and one complete response (CR) were observed. All CR/PRs were observed in the non-squamous group, representing an objective response rate (ORR) of 43% in the seven non-squamous patients. HTBA3011 was generally safe and well-tolerated in both monotherapy and in combination with nivolumab, consistent with trials to date.
New trial in 2024
“This topline data is tremendously exciting, because it not only continues to validate the CAB platform,” said Brian Zhang, Himalaya Therapeutics’ CEO, “but also presents the possibility for treatment in patients with significant unmet needs. We all know that sarcoma is a notoriously difficult cancer to treat, with no approved first-line antibody treatments, and the outlook is very poor for NSCLC patients who have failed multiple lines of therapy.”
Interim phase 2 analysis of HTBA3011 in certain sarcomas supports advancement of patients with undifferentiated pleomorphic sarcoma and osteosarcoma into part 2 of the phase 2 trial.
In phase 1 and part 1 of the phase 2 trial, PRs were observed in four of eight UPS patients. In phase 1 and part 1 of the phase 2 trial, PFS for osteosarcoma patients at three months was four of seven patients. Development and advancement for other types of sarcoma also continues.
Himalaya Therapeutics’ CMO, Howe Li, said: “Himalaya is excited about its advancing pipeline, which includes three novel product candidates in clinical trials today, and expects to have a fourth, its first bispecific, in early 2024.”
About Himalaya Therapeutics
Himalaya Therapeutics is a global clinical-stage biotechnology company advancing its pipeline of novel monoclonal antibody and other protein therapeutic product candidates through clinical trials. These have been designed to have more selective targeting, greater safety and efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies.
Its product candidates have been developed using CAB technology, which is protected by more than 500 issued and pending patents globally.