ESMO Congress 2026

Ivonescimab Beats Pembrolizumab on Overall Survival in HARMONi-2, Head to Head

Ivonescimab from Akeso became the first therapy to beat pembrolizumab head to head on overall survival in a randomized phase 3 trial, with median OS of 30.8 months versus 22.6 months and a 27% reduction in death risk in HARMONi-2. Benefit concentrated in PD-L1-high (HR=0.58) and squamous (HR=0.65) patients. The same WCLC also featured two Chinese B7-H3 ADCs, HS-20093 and YL201, each cutting death risk 54% versus topotecan in relapsed small cell lung cancer.

Ivonescimab Beats Keytruda on Overall Survival in Phase III HARMONi-2 NSCLC Trial

Ivonescimab, a PD-1/VEGF bispecific antibody, beat Merck's Keytruda on overall survival in the HARMONi-2 study, a phase III head-to-head trial in advanced NSCLC, with median OS of 30.8 months versus 22.6 months and a 27% reduction in relative risk of death. This is the first time a PD-1/VEGF bispecific has defeated Keytruda on overall survival in a phase III head-to-head trial. Akeso and Summit Therapeutics presented the data at the World Conference on Lung Cancer.

Ivonescimab Beats Pembrolizumab on Overall Survival in HARMONi-2 Phase 3 Trial

Ivonescimab, a PD-1/VEGF bispecific antibody from Akeso, has delivered full overall survival results from the phase 3 HARMONi-2 trial, with a median OS of 30.8 months versus 22.6 months for pembrolizumab monotherapy in a head-to-head comparison. Reported by Caicun Zhou of Shanghai East Hospital, this makes ivonescimab the first cancer immunotherapy to achieve positive results in both progression-free survival and overall survival against pembrolizumab in a randomized, double-blind phase 3 study. A key regulatory decision point arrives in November.

Ivonescimab Beats Pembrolizumab on Overall Survival in First-Line PD-L1-Positive Advanced NSCLC

Ivonescimab significantly extended overall survival versus pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC, meeting the prespecified statistical bar for significance. At a median follow-up of 36 months as of August 20, 2026, 234 overall survival events had occurred and median overall survival reached 30.8 months. Prespecified subgroup analyses showed a consistent survival benefit, most pronounced in patients with high PD-L1 expression.

Ivonescimab Beats Pembrolizumab on Overall Survival in PD-L1-Positive NSCLC in HARMONi-2

Ivonescimab monotherapy as first-line treatment for PD-L1-positive non-small cell lung cancer achieved a median overall survival of more than 30 months, extending survival by over 8 months compared with pembrolizumab. The phase 3 HARMONi-2 trial, led by Professor Zhou Caicun of Shanghai East Hospital and presented at the 2026 World Conference on Lung Cancer, is the first randomized double-blind phase 3 trial to show positive results for both overall survival and progression-free survival against pembrolizumab.

Ivonescimab Beats Pembrolizumab on Overall Survival in Front-line PD-L1-positive NSCLC in HARMONi-2

Ivonescimab beat pembrolizumab as first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC on overall survival in the registrational HARMONi-2 (AK112-303) trial, with the result reaching statistical significance. The randomised, double-blind, multicentre study was presented as a late-breaking oral at WCLC and included in the official press programme. The finding positions ivonescimab, from Akeso, as a competitor to pembrolizumab in this setting.

Akeso, Summit’s ivonescimab tops Keytruda in lung cancer survival, with strong data in PD-L1-high patients

Ivonescimab, from Akeso and Summit, cut the risk of death by 27% versus Keytruda in the phase 3 Harmoni-2 trial, which tested the drug as first-line treatment for PD-L1-positive non-small cell lung cancer. The survival benefit was especially pronounced in patients with high PD-L1 expression, strengthening the case for a challenger to pembrolizumab in this setting.

Upcoming FDA approval decisions in Q4 2026

Three FDA approval decisions are worth watching in Q4 2026: ifinatamab deruxtecan for previously treated small-cell lung cancer, bepirovirsen for chronic hepatitis B infection, and ivonescimab for EGFR-mutant non-small-cell lung cancer. The list was compiled by Citeline and published in Nature Reviews Drug Discovery, volume 25, page 749.

Ivonescimab Beats Pembrolizumab on Overall Survival in Phase 3 HARMONi-2

Ivonescimab, Akeso's PD-1/VEGF bispecific antibody, has beaten pembrolizumab on overall survival in the phase 3 HARMONi-2 trial, according to a company announcement on September 3. The predefined OS interim analysis passed review by the independent data monitoring committee, showing statistical significance and clinical benefit. Ivonescimab is the first bispecific antibody to outperform a PD-1 monoclonal antibody on OS in a phase 3 trial, in first-line PD-L1-positive (TPS ≥1%) locally advanced or metastatic NSCLC.

Fierce Pharma Asia—Roche, GSK, Novartis billion-dollar deals; More MFN sign-ups; Akeso’s OS win

GSK, Roche and Novartis continued striking multiple billion-dollar deals with Asian biopharmas; three midsized Asian drugmakers signed MFN pricing agreements with the White House; ivonescimab, jointly developed by Akeso and Summit, beat Keytruda on overall survival in a head-to-head trial.

Ivonescimab Beats Pembrolizumab Head-to-Head in HARMONi-2 Phase III Trial

Ivonescimab from Akesf outperformed pembrolizumab in the phase III HARMONi-2 head-to-head trial, meeting the primary endpoint of progression-free survival at interim analysis with a statistically significant result. Median PFS was 11.14 months with ivonescimab versus 5.82 months with pembrolizumab, hazard ratio 0.51. HARMONi-2 is the first phase III study to show a significant positive result against pembrolizumab.

Akeso, Summit’s ivonescimab extends lives in Keytruda head-to-head trial. What now?

Ivonescimab, the PD-1xVEGF bispecific from Akeso and Summit, has met its overall survival endpoint in a head-to-head trial against Keytruda. The result follows a progression-free survival win reported about two years ago, which had positioned the drug and its class as the leading candidate to replace Keytruda. The overall survival finding, however, has drawn a far more measured reception.

Fierce Pharma Asia—Roche’s $2.5B obesity deal; Akeso CEO’s defense; Lawmaker’s reflection on China

This week's Fierce Pharma Asia covers three industry developments: Roche struck a $2.5 billion obesity deal; Akeso's CEO publicly responded to questions about shrinking lung cancer data for ivonescimab; and a U.S. congressman said China is "beating us on our ground game," reflecting anxiety about American competitiveness in biotech.

Akeso's ivonescimab hits OS endpoint in HARMONi-GI1 study against durvalumab plus chemotherapy

Akeso announced that its PD-1/VEGF bispecific antibody ivonescimab plus chemotherapy met the OS primary endpoint at an interim analysis assessed by the IDMC in the HARMONi-GI1 study in first-line advanced biliary tract cancer, and also met key secondary endpoints of PFS and ORR. The control arm was durvalumab plus chemotherapy, the guideline-recommended optimal first-line immunotherapy regimen. Akeso shares rose as much as 8.72% on the news.

Akeso's Ivonescimab Hits Primary Endpoint in Late-Stage Head-to-Head Biliary Tract Cancer Trial

Akeso's ivonescimab met the primary endpoint in a late-stage head-to-head trial in biliary tract cancer. On the news, Akeso shares rose as much as over 8% in morning trading, lifting its market value above HK$86.7 billion. Biliary tract cancer is a recognized refractory gastrointestinal tumor with limited first-line options; ivonescimab previously achieved a breakthrough in lung cancer, and this trial extends its scope. The report gives no trial name, hazard ratio, or confidence interval.

Akeso CEO looks beyond lung cancer with biliary tract win, counters ivonescimab debate

Akeso CEO looks beyond lung cancer with biliary tract win, counters ivonescimab debate

First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial.

Ivonescimab plus paclitaxel or nab-paclitaxel as first-line therapy produced an objective response rate of 80.0% (95% CI 63.1-91.6) in 35 evaluable patients with locally advanced unresectable or metastatic triple-negative breast cancer, including 2 complete and 26 partial responses. In the 36-patient single-arm phase 2 trial, all patients had treatment-related adverse events, 58.3% were grade 3 or higher, and no treatment-related deaths occurred. The PD-1/VEGF bispecific plus chemotherapy pairing offers a first-line option for this population that merits further investigation.

NMPA Approves Akeso Ivonescimab Plus Chemo for First-Line Squamous NSCLC

On 12 August 2026, China's NMPA approved Akeso's supplemental new drug application for ivonescimab injection combined with chemotherapy as first-line treatment of advanced squamous non-small cell lung cancer. It is ivonescimab's third approved lung cancer indication. The regimen, supported by the Phase 3 HARMONi-6/AK112-306 study, is described as the first to show significant benefits in both progression-free survival and overall survival versus an anti-PD-1 antibody plus chemotherapy in a randomized, double-blind trial.

NMPA Approves Akeso's Ivonescimab Plus Chemo for First-Line Squamous NSCLC

China's NMPA has approved Akeso's ivonescimab injection plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer, the drug's third approved lung cancer indication. The approval rests on the Phase 3 HARMONi-6/AK112-306 study of 532 patients, which met all primary and secondary endpoints with statistically significant PFS and OS benefit versus PD-1 antibody plus chemotherapy and a good safety profile; OS results were presented at the 2026 ASCO plenary session and published in The Lancet.