BioNTech SE (NASDAQ:BNTX) traded 3.1% higher in Monday’s premarket session after the company, alongside partner OncoC4, released encouraging survival data for its investigational lung cancer therapy, gotistobart.
The selective Treg-modulating drug produced a marked survival advantage in patients with previously treated squamous non-small cell lung cancer (sqNSCLC) when compared with standard chemotherapy. With nearly 15 months of follow-up, the median overall survival for the gotistobart arm had not yet been reached, whereas patients receiving chemotherapy recorded a median survival of about 10 months.
In the non-pivotal portion of the global Phase 3 PRESERVE-003 study, gotistobart cut the risk of death by 54% versus docetaxel. Twelve-month survival reached 63.1% for the gotistobart group, compared with 30.3% for the chemotherapy arm.
Lead investigator Byoung Chul Cho, Professor at Yonsei Cancer Center, said, “We are encouraged by the median overall survival still not being reached for patients treated with gotistobart at almost 15 months of follow-up.”
The safety profile remained manageable: grade 3 or higher treatment-related adverse events occurred in 42.2% of patients on gotistobart, versus 48.8% in the docetaxel arm.
Gotistobart holds FDA Fast Track designation for metastatic NSCLC in patients whose disease has progressed following prior anti-PD-(L)1 therapy. The pivotal stage of the Phase 3 trial is underway across more than 160 global sites.
Clear Street analyst Bill Maughan reaffirmed a Buy rating and a $181 price target on BioNTech, noting, “Our strongest focus in the company’s pipeline is pumitamig and its potential to combine with in-house antibody drug conjugates (ADCs), but an emergence of gotistobart would add another powerful immune-oncology agent to the company’s compelling oncology growth story, which remains undervalued.”