Experimental drug gives new hope in severe lung cancer
BioNTech and OncoC4 presented impressive results for their experimental drug gotistobart on Friday. The data show that the new treatment reduces the risk of death by more than half compared to standard chemotherapy in patients who have already been treated but whose disease has progressed. This finding may prove crucial for people with one of the most difficult to treat types of cancer – squamous non-small cell lung carcinoma (NSCLC).
The results come from a global Phase 3 study called PRESERVE-003 and were announced at the prestigious IASLC/ASCO 2025 Lung Cancer Conference in Chicago. According to the data, gotistobart lowered the risk of death by 54% compared to docetaxel (standard chemotherapy), with a risk ratio of only 0.46 – a figure that is rarely seen in oncology at such advanced stages of the disease.
Even more impressive is that after nearly 15 months of observation, the median survival of patients on gotistobart has not yet been reached, while in those on chemotherapy it was only 10 months. One year after starting treatment, 63.1% of people taking the new drug were alive, compared to only 30.3% of those on standard therapy.
"In this type of cancer, the average survival is usually less than one year, which makes it extremely aggressive and difficult to treat," explains Prof. Byong Chul Cho of the Yonsei Cancer Center in Seoul and lead researcher in the study. "The fact that after almost 15 months we still haven't reached the median survival limit in patients with gotistobart is really encouraging."
How does the new drug work?
Gotistobart is not just another "strong pill", but an intelligent biological therapy. It is a monoclonal antibody that targets specific T-cells (regulatory T-cells), which often prevent the immune system from attacking the tumor. Unlike older drugs of this type, gotistobart is designed to act more precisely and spare healthy tissues, which reduces severe side effects.
The study involved 87 patients with metastatic cancer in whom previous therapies had not helped. Until now, the options for this group of patients were severely limited – mainly palliative care or toxic chemotherapy.
Safety also seems better: serious side effects were observed in 42.2% of patients on gotistobart versus 48.8% on chemotherapy. This means that the new treatment is not only more effective, but also slightly more tolerable for the body.
What's next?
The study is continuing in full swing. It is planned to include about 500 more patients in over 160 clinics around the world. In December 2024, the U.S. Food and Drug Administration (FDA) lifted the partial ban on the trial, which allowed patients to be recruited again.
The drug has already received special "accelerated review" (Fast Track) status in the US and "breakthrough therapy" status in China, highlighting the high expectations for it.
"The data we are seeing today shows that gotistobart can fill a huge void in the treatment of these patients," says Pan Zhen, chief medical officer and co-founder of OncoC4. For thousands of people with this diagnosis, this may mean not just more time, but real hope.