BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.
BioNTech, Summit Therapeutics, GSK and Roche have made a splash already at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.
BioNTech and OncoC4 report OS win for CTLA-4 drug
Ahead of its upcoming pivotal readout, BioNTech shared overall survival (OS) data for gotistobart, a next-gen anti-CTLA-4 monoclonal antibody in development with OncoC4.
The investigational drug elicited a median OS of 18.5 months for patients with metastatic squamous NSCLC (sqNSCLC) that had progressed after prior treatment, versus the 10-month median for patients on chemotherapy. The data are from the non-pivotal stage of the global PRESERVE-003 Phase 3 trial, designed to confirm the correct dose for the second portion of the study, which is currently ongoing, with an interim readout expected sometime this year.
The new findings are the first median OS results to be shared for gotistobart and build off “encouraging” 12-month OS data published in March, at which point median OS had not been reached. The most recent data further confirm the antibody’s survival advantage over chemotherapy, BMO analysts wrote Monday, with the improvement indicating the “potential for non-chemotherapy-based treatment in sqNSCLC.”
Summit and Akeso provide more positive OS data for ivonescimab
Summit Therapeutics and China-based partner Akeso shared another ivonescimab readout, this time demonstrating a 27% death risk reduction for patients with PD-L1-positive advanced non-small cell lung cancer (NSCLC) compared to Keytruda, Merck’s blockbuster PD-1 inhibitor.
The Phase 3 HARMONi-2 trial showed statistically significant OS benefit for patients receiving the investigational bispecific antibody compared to Keytruda monotherapy. Conducted in China, the trial continued to demonstrate “an acceptable and manageable safety profile,” Summit said in a Sunday release.
Ivonescimab’s survival benefit over Keytruda “show some additional class benefit,” BMO analysts wrote in a Monday note.
Earlier this month, Summit and Akeso announced that the HARMONi-2 study demonstrated a statistically significant OS advantage over standard-of-care—thereby meeting a key secondary endpoint of the trial—but didn’t provide the data behind the claim. Now, the companies have shared that ivonescimab achieved a hazard ratio (HR) of 0.73, with patients on the investigational drug achieving median OS of 30.8 months, compared with 22.6 months for those taking Keytruda.
BMO highlighted the fact that HARMONi-2 is a Chinese patient population study, “limiting interpretation to Western trials, but results still read positively to future PD-(L)1/VEGF bispecific development”—such as pumitamig from BioNTech and BMS.
“We look to global data from the HARMONi-3 trial in sqNSCLC for a better assessment of this efficacy advantage in a non-Chinese selective population,” BMO wrote.
Akeso secured China approval for ivonescimab based on the primary results of HARMONi-2 in April 2025. The drug demonstrated a statistically significant 49% improvement in progression-free survival (PFS) when compared to Keytruda.
“HARMONi-2 is the fourth Phase 3 study of ivonescimab to demonstrate statistically significant improvements for both overall survival and progression-free survival in head-to-head comparisons against standard-of-care regimens,” Summit co-CEO Robert Duggan said in a Sunday release.
GSK and Hansoh’s ris-rez hits 8 month survival advantage
GSK and China partner Hansoh Pharma shared a median OS of 18.5 months for risvutatug rezetecan (ris-rez), which reduced death risk by 54% compared to standard-of-care that was tied to an OS of 10.3 months.
The Phase 3 study included patients in China with relapsed small cell lung cancer (SCLC) that had progressed after platinum-based first-line therapy, with the statistically significant reduction scoring a primary endpoint win.
Patients receiving ris-rez also experienced fewer severe treatment-related side effects (TRAEs) than those on chemotherapy, with grade 3 or higher TRAEs occurring in 60.9% of participants compared to 78.2% of people in the control group.
The companies previously shared that the B7-H3 ADC had met the study’s main goal but didn’t share specifics at the time.
GSK paid $185 million in December 2023 to secure exclusive global rights to ris-rez outside of China, Hong Kong, Macau and Taiwan in a deal that could max out at $1.7 billion. The pharma is advancing the ADC across lung cancer, prostate cancer and other solid tumors, with pivotal data in relapsed extensive-stage SCLC expected next year.
Roche and MediLink’s tam-peli heading to Phase 3
Roche and China partner MediLink Therapeutics’ antibody drug conjugate (ADC) tambotatug pelitecan (tam-peli) scored in a Phase 3 small cell lung cancer (SCLC) with a median OS of 13.3 months. That’s significantly longer than the 9.4 OS for patients receiving standard-of-care treatment, translating to a 54% reduced risk of death for patients taking tam-peli.
Tam-peli showed a “favorable and manageable safety profile,” Roche said. The drug demonstrated lower rates of grade 3 or higher treatment-related adverse events (TRAEs) compared to chemotherapy, at 46.4% incidence compared to 74.7%. Treatment-emergent interstitial lung disease across all grades was reported in 4.9% of tam-peli patients compared to 1.4% for standard of care, with no grade 4 or 5 events reported in either group.
The data support Roche’s plans to launch global Phase 3 trials for tam-peli, the pharma said. The ADC has nabbed FDA Breakthrough Therapy designation in SCLC.
