FDA grants Orphan Drug Designation to gotistobart for squamous NSCLC following promising overall survival benefit versus docetaxel.

Der Mainzer Arzneimittelhersteller BioNTech legt positive Studien zur Krebsbehandlung mit dem Medikament Gotistobart vor. Der Börsenkurs des Unternehmens steigt zum Wochenstart.

Das deutsche Biotech-Unternehmen Biontech meldet ermutigende Ergebnisse aus einer Studie zur Behandlung einer bestimmten Form von Lungenkrebs.

BioNTech's gotistobart showed 18.5 vs 10.0 month survival vs chemo in lung cancer Phase 3, cutting death risk 44%. BNTX shares rose 3%.

BioNTech SE (NASDAQ:BNTX) reported that its investigational lung-cancer drug gotistobart produced a clinically meaningful overall-survival benefit in the

A new immunotherapy drug nearly doubled survival for advanced lung cancer patients. Gotistobart gave patients 18.5 months versus 10 months on the standard drug, cutting death risk by 43%.

BioNTech and OncoC4 said median survival reached 18.5 months with gotistobart versus 10 months with docetaxel in a non-pivotal trial stage.

If approved, immunotherapy gotistobart could offer a chemo-free option in second-line setting

Updated PRESERVE-003 data: gotistobart showed 18.5 vs 10 months median survival vs chemo in previously treated squamous NSCLC. Pivotal stage ongoing.

Patients with metastatic squamous non-small cell lung cancer (NSCLC) whose disease progressed following PD-(L)1 inhibitor therapy experienced a median overall survival of 18.5 months with the investigational anti-CTLA-4 antibody gotistobart, compared with 10.0 months for patients receiving docetaxel, according to updated findings from stage 1 of the Phase III PRESERVE-003 trial.

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David Wise, MD, PhD, NYU Langone Health, New York, NY, discusses results from the Phase I PRESERVE-006 trial (NCT05682443) of...

Florida Cancer Specialists' Phase 3 trial reveals that Gotistobart, a new immunotherapy, may improve outcomes for advanced lung cancer patients with fewer side effects.

OncoC4 announces that China's NMPA has granted Breakthrough Therapy Designation for Gotistobart (BNT316/ONC-392) aimed at treating squamous non-small cell lung cancer, enhancing prospects for patients facing limited options.

BioNTech (Nasdaq:BNTX) will present new data from its late-stage oncology pipeline at the 2026 ASCO Annual Meeting in Chicago, May 29–June 2.Key highlights include interim Phase 2/3 ROSETTA Lung-02 data for pumitamig in first-line NSCLC and Phase 2 PRESERVE-004 overall survival data for gotistobart in platinum-resistant ovarian cancer, plus multiple ADC and novel-novel combination trial updates across more than 25 Phase 2/3 studies, including 13 pivotal trials.

BioNTech (Nasdaq: BNTX) will present late-stage lung cancer data at ELCC 2026 (March 25-28), highlighting updates on pumitamig, gotistobart and the HER3-targeted ADC BNT326/YL202. Key clinical notes include a reported 54% reduction in risk of death for gotistobart versus chemotherapy in stage 1 PRESERVE-003 and multiple China-based trial updates for pumitamig supporting ongoing global Phase 2/3 and Phase 3 programs.The portfolio now spans 16 ongoing lung cancer trials, including four pivotal Phase 3 studies and five novel-novel combination trials.