Ivonescimab beats Keytruda on overall survival and nears FDA decision
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Ivonescimab, a PD-1 x VEGF bispecific antibody jointly developed by Akeso and Summit Therapeutics, has become the leading challenger to pembrolizumab. In the phase 3 HARMONi-2 trial in first-line PD-L1-positive advanced NSCLC, led by Professor Zhou Caicun of Shanghai East Hospital and presented at the 2026 World Conference on Lung Cancer, it cut the risk of death by 27% versus pembrolizumab, with median overall survival of 30.8 months at 36 months' follow-up — the first randomized double-blind phase 3 trial positive on both OS and PFS against pembrolizumab. The drug is under US regulatory review in NSCLC with a PDUFA date of 14 November. Most recently, AstraZeneca and Daiichi Sankyo signed a pact with Summit to test their ADC Datroway alongside ivonescimab, starting with a phase III study in frontline triple-negative breast cancer, following AstraZeneca's $2 billion equity investment. Open questions include the FDA's decision and how the class competes beyond lung cancer.
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- mp.weixin.qq.comPickHARMONi-2 Shows Positive OS for Ivonescimab in First-Line PD-L1-Positive NSCLC
At the 2026 WCLC, the HARMONi-2 study presented updated overall survival data for ivonescimab versus pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC, showing a median OS of 30.8 months and a statistically significant, clinically meaningful positive OS result. Professor Chu Qian's interpretation noted consistent benefit across subgroups, with median OS exceeding three years in patients with high PD-L1 expression.
- mp.weixin.qq.comAkeso to raise about HK$1.94 billion in share placement as ivonescimab takes on PD-1
Akeso (09926.HK) plans to place 20 million new shares at HK$97.76 each, a 6.90% discount to the previous close, through Morgan Stanley Asia to at least six placees. The placement would raise about HK$1.955 billion gross and HK$1.941 billion net. The company's bispecific antibody ivonescimab is positioned to challenge PD-1 inhibitors as first-line standard treatment in lung cancer.
- mp.weixin.qq.comPickIvonescimab Beats Pembrolizumab on Overall Survival in Frontline PD-L1-Positive Advanced Lung Cancer
Ivonescimab, Akesu's bispecific antibody, beat pembrolizumab head-to-head as first-line monotherapy in PD-L1-positive advanced lung cancer, with median overall survival of 30.8 months versus 22.6 months. The risk of death fell 27 percent, with P value 0.009, a statistically significant result presented at the World Conference on Lung Cancer. Pembrolizumab, long the world's top-selling drug at 31.68 billion dollars a year, now faces a direct survival challenge.
- mp.weixin.qq.comAstraZeneca Bets $2 Billion on Ivonescimab to Find a Next-Generation Partner for ADCs
AstraZeneca has placed a $2 billion bet on ivonescimab, aiming to find a next-generation partner for its ADCs. The deal centers on ivonescimab and is intended to strengthen its pipeline positioning in ADC combination therapy.
- pharmaceutical-technology.comAstraZeneca deepens Summit ties on ADC-bispecific cancer combo testing pact
AstraZeneca and Daiichi Sankyo have signed a deal with Summit Therapeutics to test their ADC Datroway (datopotamab deruxtecan) alongside Summit's PD-1 x VEGF bispecific antibody ivonescimab in several tumour types, starting with a Phase III study in frontline triple-negative breast cancer. Daiichi and Summit will share trial costs, and each keeps rights to its own medicine. The pact follows AstraZeneca's $2bn equity investment in Summit for an estimated 12% stake and a separate deal on the CLDN18.2-targeting ADC sonesitatug vedotin combined with ivonescimab; ivonescimab is under US regulatory review in NSCLC with a PDUFA date of 14 November.
- biopharmadive.com5 FDA decisions to watch in the fourth quarter of 2026
BioPharma Dive rounds up five FDA decisions to watch in the fourth quarter of 2026, including Summit and Akeso's PD-1/VEGF bispecific antibody ivonescimab, Roche's giredestrant, and anito-cel.
- biospace.comAstraZeneca buys into Summit, UniQure drops on 4-year data, FDA on a roll
AstraZeneca is investing $2 billion in Summit Therapeutics in an all-stock deal to support Phase 3 trials of ivonescimab, the PD-1/VEGF bispecific partnered with Akeso. Four-year data from uniQure's Phase 1/2 trial of its Huntington's disease gene therapy showed a 44% slowing of disease progression, down sharply from 75% at three years, sending shares down nearly 40%. FDA approvals have been active recently, with AbbVie, Eli Lilly, Merck and Mirum Pharmaceuticals all winning approvals in the past week.
- mp.weixin.qq.comPickAstraZeneca Takes $2 Billion Stake of About 12% in Summit Therapeutics
AstraZeneca will invest $2 billion in Summit Therapeutics by subscribing to convertible preferred shares, giving it about 12% of the company after conversion. Alongside the equity stake, announced September 28, the two firms signed a binding clinical collaboration combining Sone-Ve with Ivonescimab in GI tumors, plus a non-binding MOU to explore pairing Ivonescimab with more of AstraZeneca's ADC portfolio.
- mp.weixin.qq.comPickAstraZeneca Takes $2 Billion Stake in Summit, Ivonescimab Overseas Rights Holder
AstraZeneca invested $2 billion in convertible preferred shares of Summit, the holder of overseas rights to Akeso's PD-1/VEGF bispecific antibody ivonescimab, taking roughly a 12% stake. The deal, disclosed on September 28, 2026, gives AstraZeneca no rights to the drug itself but makes it the sponsor of clinical trials combining ivonescimab with its own ADC. Summit shares rose about 18% after hours and Akeso's Hong Kong shares gained more than 15% the next day.
- biospace.comPickSummit snags $2B investment from AstraZeneca, clearing financial overhang
AstraZeneca is investing $2 billion in Summit Therapeutics through a direct equity purchase of about 109,000 preferred shares, giving it roughly 12% of Summit's common shares at $18.36 per share, a 10% premium. The deal, expected to close within a week pending regulatory clearances, lifts Summit's cash to an estimated $2.5 billion and leaves it holding full rights to ivonescimab, the PD-1/VEGF bispecific, in its territories. The partners will also start trials pairing AstraZeneca's anti-CLDN18.2 ADC sonesitatug vedotin with ivonescimab in gastrointestinal cancers, while the FDA decides Summit's BLA for the NSCLC drug by Nov. 14.
- biopharmadive.comAstraZeneca invests $2B in Summit, gaining ‘seat at the table’ for PD-1/VEGF drug push
AstraZeneca will invest $2 billion in Summit Therapeutics by buying about 109,000 shares of convertible preferred stock, giving it roughly 12% ownership, or about 10.6% fully diluted. The companies will jointly test Summit's PD-1/VEGF drug ivonescimab with AstraZeneca medicines, starting with the ADC "Sone-Ve" in gastrointestinal tumors, and will share development costs while retaining rights to their own drugs. Ionescimab previously halved the risk of progression or death versus Keytruda in a Phase 3 lung cancer study, and the partnership may expand to further combinations.
- mp.weixin.qq.comAstraZeneca Pays $2 Billion for 12% of Summit Therapeutics to Back Ivonescimab
AstraZeneca will invest $2 billion in Summit Therapeutics for a 12% stake, buying convertible preferred shares at $18.36 each, an 18.6% premium to the September 28 closing price of $15.48. The deal backs ivonescimab, a bispecific antibody originating in China that is positioned to challenge Merck's Keytruda, and provides fresh funding for Summit. The investment marks full endorsement of the drug by a multinational pharma company.
- mp.weixin.qq.comAstraZeneca Invests $2 Billion in Summit Therapeutics to Advance Ivonescimab-ADC Combinations
AstraZeneca and Summit Therapeutics have agreed a collaboration under which AstraZeneca will buy preferred shares in Summit for roughly $2 billion, giving it about 12.0% of Summit's issued equity. The deal supports joint development of ivonescimab in combination with AstraZeneca's antibody-drug conjugates. No development timelines were given.
- mp.weixin.qq.comAstraZeneca Invests 2 Billion Dollars in Summit, Overseas Partner for Akeso's Ivonescimab
AstraZeneca has invested 2 billion US dollars for a stake in Summit, the overseas partner for Akeso's product ivonescimab. The deal sent Akeso's shares up more than 13% and lifted the broader innovative-drug sector in Hong Kong.
- mp.weixin.qq.comAstraZeneca to Invest $2 Billion in Summit to Co-develop PD-1/VEGF Bispecific Ivonescimab
AstraZeneca and Summit have agreed a $2 billion equity investment in convertible preferred shares, equating to $18.36 per common share at conversion, above the closing price at the time. The deal concerns ivonescimab, a PD-1/VEGF bispecific antibody being studied in multiple late-stage trials worldwide, including international multicentre registrational studies led by Summit. The companies will collaborate on developing the drug, with conversion of the preferred shares to follow.
- mp.weixin.qq.comAstraZeneca Invests Up to $2 Billion in Summit, Pairing Sone-Ve ADC With Ivonescimab
AstraZeneca has secured rights to Summit Therapeutics' PD-1/VEGF bispecific antibody ivonescimab in a deal worth up to $2 billion. The companies will also run a clinical collaboration to evaluate sonesitatug vedotin (Sone-Ve) in combination with ivonescimab. Summit shares rose 17% in premarket trading on the news.
- mp.weixin.qq.comAstraZeneca Takes $2 Billion Stake in Summit for ADC Plus Ivonescimab Collaboration
AstraZeneca is taking a $2 billion equity stake in Summit and has signed a clinical collaboration to evaluate sonesitatug vedotin combined with ivonescimab in certain gastrointestinal cancers, with studies planned to start as soon as possible. The companies also signed a memorandum of understanding to explore combinations of ivonescimab with a range of AstraZeneca ADCs and other oncology drugs.
- mp.weixin.qq.comPickIvonescimab Beats Pembrolizumab on Overall Survival in Frontline PD-L1-Positive Advanced NSCLC
Ivonescimab extended median overall survival to 30.8 months versus 22.6 months for pembrolizumab in first-line treatment of PD-L1-positive (TPS ≥1%) advanced non-small cell lung cancer, cutting the risk of death by 27%. Data presented by Caicun Zhou of Shanghai East Hospital at the 2024 WCLC make ivonescimab the first drug to beat pembrolizumab head-to-head in a phase 3 trial with positive results on both progression-free and overall survival.
- mp.weixin.qq.comPickIvonescimab Reaches 16.9-Month PFS After Third-Generation EGFR-TKI Resistance in NSCLC
Ivonescimab, a PD-1/VEGF bispecific antibody, delivered a median progression-free survival of 16.9 months in patients with locally advanced or metastatic non-squamous NSCLC whose disease progressed on third-generation EGFR-TKI treatment, compared with 4-5 months for traditional chemotherapy in this setting. China's NMPA has approved it for this population, giving third-generation EGFR-TKI-resistant disease a new treatment standard.
- mp.weixin.qq.comPickIvonescimab Beats Pembrolizumab on Overall Survival in HARMONi-2 Trial
Ivonescimab, Akesu Bio's PD-1/VEGF bispecific antibody, beat pembrolizumab as first-line monotherapy in PD-L1-positive non-small cell lung cancer in the HARMONi-2 trial. Median overall survival was 30.8 months versus 22.6 months with pembrolizumab, HR=0.73, P=0.009, presented by Professor Zhou Caicun at the WCLC presidential symposium. It is the first drug to beat pembrolizumab in a randomized controlled trial on two endpoints.
- FiercePharmaFierce Pharma Asia—China deals safe from COINS?; Key WCLC data; Legend’s new CEO
Reuters reports that COINS rules being drafted by the U.S. Treasury Department are expected not to affect most licensing deals by Chinese drugmakers. WCLC26 highlights include data on ivonescimab from Akeso and Summit, B7-H3 ADCs, and an unexpected negative overall survival trend for Enhertu. Legend has named a new CEO.
- vbdata.cnPickIvonescimab 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.
- mp.weixin.qq.comPickIvonescimab 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.
- mp.weixin.qq.comPickIvonescimab 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.
- mp.weixin.qq.comPickIvonescimab 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.
- mp.weixin.qq.comPickIvonescimab 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.
- mp.weixin.qq.comPickIvonescimab 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.
- fiercepharma.comPickAkeso, 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.
- nature.comUpcoming 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.
- mp.weixin.qq.comPickIvonescimab 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.
- fiercepharma.comFierce 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.
- mp.weixin.qq.comPickIvonescimab 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.
- fiercepharma.comPickAkeso, 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.
- FiercePharmaFierce 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.
- mp.weixin.qq.comPickAkeso'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.
- mp.weixin.qq.comPickAkeso'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.
- Nat MedPickFirst-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.
- mp.weixin.qq.comPickNMPA 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.
- vbdata.cnPickNMPA 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.
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