New Anti-CTLA-4 Therapy Shows Promise for Pretreated NSCLC Patients

Gotistobart demonstrates improved overall survival compared to chemotherapy in phase 3 trial.

Apr. 6, 2026 at 8:34am

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Early results from the first stage of a phase 3 trial suggest that gotistobart, a new antibody targeting anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), has potential as a chemotherapy-free treatment for certain patients with previously treated non-small cell lung cancer (NSCLC). The study found that gotistobart monotherapy improved overall survival compared to docetaxel chemotherapy in patients with metastatic squamous NSCLC.

Why it matters

The findings indicate that gotistobart, a novel CTLA-4 inhibitor, could offer a new treatment option for NSCLC patients who have progressed after prior immunotherapy and chemotherapy. Improving outcomes for this patient population is an important clinical need, as prognosis is often poor for those who fail initial standard-of-care therapies.

The details

In the first stage of the PRESERVE-003 trial, 87 patients with metastatic squamous NSCLC who had previously received a PD-L1 or PD-1 inhibitor and platinum-based chemotherapy were randomly assigned to receive either gotistobart (n=45) or docetaxel (n=42). Patients on the gotistobart arm received 6 mg/kg every 3 weeks with two loading doses of 10 mg/kg, while those on docetaxel received 75 mg/m2 every 3 weeks.

  • After a median follow-up of 14.5 months, overall survival had not been reached in the gotistobart arm compared to 9.95 months in the docetaxel arm.
  • The objective response rate was 20% with gotistobart versus 4.8% with docetaxel, and the median duration of response was 11.0 months versus 3.8 months, respectively.

The players

Kai He, MD

The study author who presented the results at the European Lung Cancer Congress 2026. He was a medical oncologist at The Ohio State University's James Cancer Hospital in Columbus, Ohio at the time of the trial.

Jhanelle E. Gray, MD

The invited discussant who compared the results to several other trials of second-line squamous NSCLC. She is the chair of thoracic oncology at H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida.

OncoC4

The pharmaceutical company that sponsored the PRESERVE-003 study.

BioNTech SE

The company that conducted and collaborated on the PRESERVE-003 study.

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What they’re saying

“The observed overall safety profile of gotistobart aligns with its previously established safety profile.”

— Kai He, MD, Study Author

“For gotistobart (anti-CTLA-4), in patients with squamous NSCLC, where over 80% of patients were previously treated with chemoimmunotherapy, the early OS data are intriguing. We obviously await stage I and stage II results of the PRESERVE-003 study.”

— Jhanelle E. Gray, MD, Invited Discussant

What’s next

The PRESERVE-003 trial will continue with stage II to further evaluate the efficacy and safety of gotistobart in this patient population.

The takeaway

The promising overall survival and response rate data for gotistobart in previously treated squamous NSCLC patients suggest this novel anti-CTLA-4 therapy could provide a much-needed new treatment option for this difficult-to-treat cancer subtype.