What You Should Know
- Gotistobart nearly doubled median overall survival in previously treated squamous non‑small cell lung cancer (NSCLC), extending survival to 18.5 months vs. 10.0 months with docetaxel (chemotherapy) in the PRESERVE‑003 Phase 3 trial.
- The therapy delivered a statistically significant, clinically meaningful benefit (HR 0.56; nominal p=0.0295), meaning gotistobart lowered the chance of dying during the study period by about 44%, meaning patients lived longer compared with chemotherapy.
- Side effects with gotistobart were about the same as with standard chemotherapy. With gotistobart, the most common side effects were diarrhea and temporary liver‑enzyme changes.
- These results, presented at the World Conference on Lung Cancer 2026, mark one of the most promising advances in a setting where survival typically remains under a year, and treatment options have stagnated for more than a decade.
New clinical trial results presented at the 2026 IASLC World Conference on Lung Cancer (WCLC) show that gotistobart (BNT316/ONC‑392) delivered a strong overall survival advantage compared with standard‑of‑care chemotherapy, nearly doubling median survival for patients whose cancer had progressed after both immunotherapy and chemotherapy.
Read MoreThese findings come from the first median overall survival analysis of the non‑pivotal Stage 1 portion of the global randomized Phase 3 PRESERVE‑003 trial (NCT05671510).
‘We Need to Study More Patients’
This is actually the second survival readout from this trial. An earlier interim analysis, published in Nature Medicine after 14.5 months of follow-up, showed that gotistobart’s median OS had not yet been reached (with docetaxel at 10.0 months, HR 0.46). The new WCLC 2026 data reflect a more mature analysis after 25.4 months of follow-up — long enough for gotistobart’s median OS to finally be reached at 18.5 months.
For a patient population that has long faced limited options and poor outcomes, the results represent one of the most encouraging signals seen in years.
Again, Dr. Flores urges a bit of conservative caution.
“I think we have to be careful about saying the drug “nearly doubled survival.” This was fewer than 90 patients, and this was the exploratory first part of the trial. The larger confirmatory portion is still ongoing. A difference this large is exciting, but we need to see if it holds up when you study more patients.”
A Clear Survival Advantage in a High‑Need Population
The trial enrolled 87 patients with metastatic squamous NSCLC who had already received and progressed on both immunotherapy and chemotherapy.
Participants were randomized to receive either gotistobart monotherapy (45 patients) or docetaxel, the long‑standing standard-of-care chemotherapy (42 patients).
With a median follow‑up of 25.4 months, the survival difference was unmistakable.
- Median overall survival (OS): 18.5 months with gotistobart vs. 10.0 months with docetaxel
- Hazard ratio: 0.56, indicating a 44% reduction in the risk of death
- Nominal p-value: 0.0295, supporting statistical significance
“In the updated analysis presented at WCLC, the HR actually moved from 0.46 in the earlier analysis to 0.56 with longer follow-up. The survival benefit remains substantial, but the apparent treatment effect became somewhat smaller as the data matured. That is exactly why the ongoing pivotal Stage 2 matters,” Dr. Flores tells SurvivorNet.
For context, current survival expectations for patients in this setting remain less than one year, even with established therapies, according to Dr. Rama Balaraman, Principal Investigator at Ocala Oncology Center.
Dr. Balaraman also noted that chemotherapy has remained the default option for more than a decade — not because it is highly effective, but because no alternative has meaningfully improved outcomes.
Gotistobart’s performance in PRESERVE‑003 challenges that long‑standing reality.
A Manageable Safety Profile
The safety profile of gotistobart remained consistent with earlier studies. Rates of grade ≥3 treatment‑related adverse events were comparable between arms:
- Gotistobart: 44.4%
- Docetaxel: 48.8%
Side effects with gotistobart were about the same as with standard chemotherapy. Most people in both groups had some treatment‑related side effects, and serious side effects occurred at similar rates according to data published in the medical journal Nature Medicine.
With gotistobart, the most common side effects were diarrhea and temporary liver‑enzyme changes, reflecting its immune-related mechanism. With docetaxel, anemia and low white blood cell counts were more common, consistent with its effects on bone marrow.
This balance between efficacy and tolerability strengthens the case for gotistobart as a potential new standard for patients who have exhausted frontline options.
Why These Results Matter for Patients
Squamous NSCLC has historically lagged behind other lung cancer subtypes in treatment advances. While immunotherapy transformed first‑line treatment, patients who progress after immunotherapy and chemotherapy have had few meaningful options.
Docetaxel (chemo) — a drug introduced decades ago — has remained the fallback.
The PRESERVE‑003 data suggest that gotistobart may finally offer a more effective path forward.
If these results are confirmed in the pivotal portion of the Phase 3 trial, gotistobart could become the first therapy in years to redefine expectations for second‑line and later treatment of squamous NSCLC.
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