Results from the Phase 3 PRESERVE-003 trial show that the immunotherapy gotistobart significantly outperforms standard chemotherapy in patients with previously treated advanced squamous non-small cell lung cancer. Compared to docetaxel, gotistobart reduced the risk of death by 54% and more than doubled the 12-month survival rate (63.1% vs. 30.3%). Median overall survival has not yet been reached with gotistobart, while it was about 10 months with chemotherapy. Response rates were also higher (20% vs. 4.8%), and responses lasted much longer.
The treatment showed a different safety profile. Gotistobart commonly caused diarrhea and elevated liver enzymes, while chemotherapy led to more anemia and low white blood cell counts. However, immune-related side effects were more frequent and severe with gotistobart, sometimes requiring steroids and leading to treatment discontinuation.
The benefit was limited to squamous disease, as no improvement was seen in non-squamous patients. The trial is now moving forward with a larger group of squamous lung cancer patients to confirm these promising results.