Overall Survival

The TROPION-Breast02 phase 3 trial, presented at ESMO 2025, shows DATROWAY significantly improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy in locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) patients ineligible for immunotherapy. DATROWAY reduced the risk of disease progression or death by 43% and improved median OS by 5 months. The objective response rate was 62.5% with DATROWAY versus 29.3% with chemotherapy, and median duration of response was 12.3 versus 7.1 months, respectively.

Merck and Eisai announced five-year follow-up data from the Phase 3 KEYNOTE-775/Study 309 trial, demonstrating a sustained survival benefit of KEYTRUDA plus LENVIMA compared to chemotherapy in patients with advanced endometrial carcinoma. For pMMR patients, the five-year OS rate was 16.7% for the combination versus 7.3% for chemotherapy. These long-term results offer a promising treatment option for this aggressive cancer, despite the associated adverse events. The combination is approved in the U.S., EU, and Japan for specific patients.

The FLAURA2 Phase III trial demonstrated that TAGRISSO® (osimertinib) combined with chemotherapy significantly improved overall survival (OS) compared to TAGRISSO monotherapy in 1st-line EGFRm NSCLC. The combination therapy achieved a median OS of 47.5 months versus 37.6 months with monotherapy, reducing the risk of death by 23%. The safety profile was manageable, reinforcing TAGRISSO as a standard of care and backbone therapy across EGFRm lung cancer stages.

Summit Therapeutics announced positive Phase III HARMONi trial data for ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients who progressed after EGFR-TKI treatment. While the primary analysis showed a positive OS trend (HR=0.79, p=0.057), longer follow-up of Western patients demonstrated improved OS (HR=0.78, p=0.0332). North American patients showed a promising OS HR of 0.70. Ivonescimab’s safety profile was consistent with prior studies. A conference call will be held September 8, 2025, to discuss these findings.

Bicara Therapeutics presented positive Phase 1/1b trial data for ficerafusp alfa, a bifunctional antibody, combined with pembrolizumab in first-line recurrent/metastatic head and neck cancer. The results, particularly in HPV-negative patients, showed significant antitumor activity, including a median duration of response of 21.7 months, median overall survival of 21.3 months, and a two-year overall survival rate of 46%. The data supports the advancement of the FORTIFI-HN01 pivotal trial.

Actuate Therapeutics announced positive Phase 2 results for elraglusib in previously untreated metastatic pancreatic cancer. The combination with gemcitabine/nab-paclitaxel significantly improved overall survival to 10.1 months, compared to 7.2 months for the control, with a 37% reduction in death risk. The 12-month survival rate also doubled. Actuate plans to discuss product registration with the FDA.

A Phase 3 trial (PANOVA-3) showed that Tumor Treating Fields (TTFields) therapy combined with gemcitabine and nab-paclitaxel improved overall survival in patients with unresectable, locally advanced pancreatic cancer and reduced pain duration compared to chemotherapy alone. The results are published in the *Journal of Clinical Oncology* and will be presented at ASCO. Novocure plans to submit the data to the FDA for approval.

Genentech announced positive overall survival data from the Phase III INAVO120 study, showing that the Itovebi regimen reduced death risk by over 30% in advanced breast cancer patients with PIK3CA mutations. Compared to palbociclib and fulvestrant alone, this Itovebi combination with palbociclib and fulvestrant significantly improved overall survival. The findings will be presented at the 2025 ASCO meeting.