This section highlights FDA-related milestones and regulatory updates for drugs developed by Summit Therapeutics (SMMT).
Over the past two years, Summit Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ivonescimab, SMT112, and AK112-306. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Ivonescimab FDA Regulatory Timeline and Events
Ivonescimab is a drug developed by Summit Therapeutics for the following indication: For Lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ivonescimab
- Announced Date:
- March 27, 2026
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2026 European Lung Cancer Congress (ELCC 2026) in Copenhagen, Denmark.
AI Summary
Summit Therapeutics announced that updated data for its novel, potential first-in-class investigational bispecific antibody ivonescimab will be presented at the 2026 European Lung Cancer Congress (ELCC 2026) in Copenhagen. Three poster presentations will feature new results, including reported intracranial anti-tumor activity from the global HARMONi Phase III study program.
Ivonescimab was engineered by Akeso and is being tested in multiple Phase III trials across lung and other cancers. More than 4,000 patients have received ivonescimab in clinical studies worldwide, and over 60,000 patients have been treated when including its commercial use in China, where it received marketing approval in May 2024.
The HARMONi program includes several Phase III trials comparing ivonescimab (as monotherapy or with chemotherapy) against established therapies in first-line metastatic non-small cell lung cancer and other indications. Summit’s ELCC presentations will provide updated efficacy and safety data from these global studies.Read Announcement
- Drug:
- Ivonescimab
- Announced Date:
- January 29, 2026
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced that the U.S. Food & Drug Administration (FDA) has accepted for filing Summit's Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy.
AI Summary
Summit Therapeutics announced that the U.S. Food & Drug Administration has accepted for filing its Biologics License Application (BLA) seeking approval of ivonescimab in combination with platinum-doublet chemotherapy for patients with EGFR‑mutated, locally advanced or metastatic non-squamous non‑small cell lung cancer who have progressed after third‑generation EGFR tyrosine kinase inhibitor therapy. The BLA is based on the overall results of the global Phase III HARMONi study, which compared ivonescimab plus chemotherapy to placebo plus chemotherapy in this post‑TKI patient population.
The FDA set a PDUFA goal action date of November 14, 2026. Summit highlighted a significant unmet need in this setting, estimating more than 14,000 U.S. patients may be eligible for treatment each year. If approved, ivonescimab plus chemotherapy would provide a new treatment option for patients whose disease has advanced after prior targeted therapy, and Summit will continue working through the regulatory review process.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- January 12, 2026
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for ivonescimab, the novel, first-in-class investigational bispecific antibody, in combination with chemotherapy in second-line or later treatment of patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
AI Summary
Summit Therapeutics announced it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval for ivonescimab, a novel, first-in-class investigational bispecific antibody, in combination with chemotherapy for second-line or later treatment of patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer. The submission, made in the fourth quarter of 2025, was based on the overall results of the global Phase III HARMONi trial.
HARMONi compared ivonescimab plus platinum-doublet chemotherapy to placebo plus chemotherapy in patients whose cancer progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor. If the FDA accepts the BLA as submitted, Summit anticipates a regulatory decision by the fourth quarter of 2026.
Ivonescimab is engineered to block PD-1 and VEGF in a single molecule, combining immunotherapy and anti-angiogenesis effects with cooperative binding that may favor the tumor microenvironment. Summit hopes this design will improve outcomes and tolerability when added to chemotherapy in this difficult-to-treat patient group.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- November 7, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc. today noted that our partner, Akeso, Inc. ("Akeso," HKEX Code: 9926.HK) published results from the Phase III HARMONi-A trial, conducted in China and sponsored by Akeso, featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab.
AI Summary
Summit Therapeutics noted that partner Akeso published results from the Phase III HARMONi-A trial conducted in China and presented at SITC 2025. The study tested ivonescimab, a novel, potential first‑in‑class bispecific antibody that combines PD‑1 blockade with VEGF inhibition, given with chemotherapy.
HARMONi-A enrolled patients with EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC who progressed after EGFR TKI therapy. This was the first Phase III trial of ivonescimab and the first to show a statistically significant overall survival (OS) benefit for an ivonescimab regimen.
In the final OS analysis (data cut‑off April 2025, median follow‑up 32.5 months), median OS was 16.8 months for ivonescimab plus chemotherapy versus 14.1 months for chemotherapy alone (HR 0.74; p=0.019). Akeso reported a favorable benefit‑risk profile and manageable safety; discontinuations for treatment‑related adverse events were 11.2% vs 6.2%, with one TRAE‑related death in each arm.
Akeso also noted that more than 40,000 patients in China have received ivonescimab in clinical or commercial settings, supporting its potential impact for patients with limited options.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- October 19, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc. announced results from the Phase III HARMONi-6 trial, conducted in China and sponsored by our partner, Akeso, Inc. (HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab.
AI Summary
Summit Therapeutics Inc. announced results from the Phase III HARMONi-6 trial in China, sponsored by partner Akeso, Inc. The study compared ivonescimab, a first-in-class bispecific antibody, plus platinum-based chemotherapy against tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer, regardless of PD-L1 status.
In interim analysis, ivonescimab plus chemotherapy achieved a median progression-free survival of 11.14 months versus 6.90 months for the tislelizumab arm, with a hazard ratio of 0.60. Both overall response rate and duration of response were higher with ivonescimab across PD-L1 subgroups. These data were published in The Lancet.
Ivonescimab’s safety profile was manageable, with similar rates of serious adverse events, discontinuations (3.4% vs. 4.2%) and deaths (3.0% vs. 3.8%) compared to the control arm. Summit’s global HARMONi-3 trial will analyze squamous cohort enrollment in H1 2026 with data in H2 2026, and non-squamous cohort enrollment in H2 2026 with data in H1 2027.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- October 17, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc. announced the expansion of its Phase III clinical development program of the novel, potential first-in-class investigational bispecific antibody, ivonescimab, into colorectal cancer (CRC) with the initiation of the global Phase III HARMONi-GI3 trial.
AI Summary
Summit Therapeutics announced the expansion of its Phase III program of ivonescimab into colorectal cancer with the HARMONi-GI3 trial.
The study will compare ivonescimab plus chemotherapy to bevacizumab plus chemo in about 600 patients with metastatic colorectal cancer, and trial sites in the United States are set to activate before year end.
The main goal is to improve progression-free survival in patients whose tumors are mismatch repair–proficient, a group with few new approved options.
Earlier Phase II results showed that ivonescimab plus FOLFOXIRI chemotherapy achieved an objective response rate of 81.8% and a disease control rate of 100% in 22 patients, with no side effects causing discontinuation.
Summit’s co-CEOs said this trial marks the first study of ivonescimab beyond lung cancer and could bring immunotherapy benefits to patients with microsatellite stable colorectal cancer who face limited treatment choices today.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- September 24, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced that data from the Phase III HARMONi-6 trial, conducted in China and sponsored by our partner, Akeso, Inc. (HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be featured as part of the Presidential Symposium at the European Society for Medical Oncology 2025 Congress (ESMO 2025) which takes place from October 17–21, 2025, in Berlin, Germany.
AI Summary
Summit Therapeutics announced that data from the Phase III HARMONi-6 trial, conducted in China by partner Akeso, will be featured in the Presidential Symposium at the ESMO 2025 Congress in Berlin, Germany. The session is set for Sunday, October 19, 2025, from 4:30pm to 6:30pm CET.
HARMONi-6 evaluated ivonescimab, a novel bispecific antibody, combined with platinum-based chemotherapy against tislelizumab plus chemotherapy in patients with advanced squamous non-small cell lung cancer, regardless of PD-L1 status. At a planned interim review, ivonescimab plus chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival by independent central review. No new safety concerns were identified. This is the first Phase III trial to demonstrate such a benefit over an anti-PD-(L)1 antibody combined with chemotherapy in a head-to-head setting.
The results will be presented by Dr. Shun Lu during the Presidential Symposium on October 19, 2025, at ESMO in Berlin.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- September 7, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced data from the Phase III HARMONi trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab.
AI Summary
Summit Therapeutics Inc. announced updated overall survival (OS) data from its global Phase III HARMONi trial of ivonescimab, a novel PD-1/VEGF bispecific antibody that could be first in its class. The trial showed a favorable OS hazard ratio (HR) of 0.78 with a nominal p-value of 0.0332, indicating a 22% reduction in the risk of death. In North American patients, the benefit was even stronger, with an OS HR of 0.70.
Ivonescimab had already demonstrated clinically meaningful and statistically significant progression-free survival (PFS) outcomes in the same trial. These benefits were consistent across both Western and Asian patient groups, mirroring results from the HARMONi-A study in China.
The safety profile remained favorable, with no new concerns identified. Together, these data support ivonescimab’s potential to provide rapid disease control and survival advantages for a broad range of lung cancer patients worldwide.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- August 14, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc. announced that data from the Phase III HARMONi trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented as part of the Presidential Symposium at the International Association for the Study of Lung Cancer's (IASLC) 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona on Sunday, September 7, 2025, at 8:15am CET (2:15am ET).
AI Summary
Summit Therapeutics announced that data from the Phase III HARMONi trial of ivonescimab, a novel potential first-in-class bispecific antibody, will be featured in the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona on Sunday, September 7, 2025 at 8:15am CET (2:15am ET).
HARMONi is a global, double-blind, placebo-controlled study comparing ivonescimab plus platinum-doublet chemotherapy against chemotherapy alone in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after third-generation EGFR tyrosine kinase inhibitors. This marks the second consecutive year ivonescimab will be featured in the WCLC Presidential Symposium.
The presentation, titled “Ivonescimab vs Placebo Plus Chemo, Phase 3 in Patients with EGFR+ NSCLC Progressed with 3rd gen EGFR-TKI Treatment: HARMONi,” will be delivered by Jonathan Goldman, MD, Professor of Medicine at UCLA.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- May 30, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced topline results from the Phase III clinical trial, HARMONi, the first global Phase III study evaluating ivonescimab, successfully met the progression-free survival (PFS) primary endpoint and showed a positive trend in the other primary endpoint, overall survival (OS).
AI Summary
Summit Therapeutics Inc. announced promising topline results from the Phase III HARMONi trial, the first global study to assess ivonescimab in patients with advanced non-small cell lung cancer. In this multiregional, double-blinded study, ivonescimab combined with chemotherapy met the primary endpoint of progression-free survival (PFS) by significantly reducing the risk of disease progression or death compared to chemotherapy alone. Additionally, a positive trend in overall survival (OS) was observed, suggesting potential benefits for patients even in a setting where few treatments have shown survival improvements. The results were consistent with those from the single-region HARMONi-A trial, reinforcing the drug’s potential effectiveness across different populations. Based on these findings, Summit Therapeutics will soon determine the appropriate timing for filing a Biologics License Application with the FDA.
Read Announcement - Drug:
- Ivonescimab
- Announced Date:
- April 25, 2025
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced that ivonescimab was approved by the Chinese Health Authorities, the National Medical Products Administration (NMPA), for a second indication based on the results of the Phase III clinical trial, HARMONi-2 or AK112-303.
AI Summary
Summit Therapeutics Inc announced that the Chinese Health Authorities, specifically the National Medical Products Administration (NMPA), approved ivonescimab for a second indication. This decision was based on results from the Phase III HARMONi-2 clinical trial (also known as AK112-303), which compared ivonescimab monotherapy to pembrolizumab monotherapy in patients with advanced non-small cell lung cancer (NSCLC) showing positive PD-L1 expression. An interim overall survival analysis revealed a hazard ratio of 0.777, indicating a potential numerical 22% reduction in the risk of death compared to pembrolizumab. The promising data from HARMONi-2 supports the potential of ivonescimab as a next-generation PD-1 directed immunotherapy, offering new treatment possibilities for patients facing advanced NSCLC.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- September 16, 2024
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced that data for the novel, potential first-in-class investigational bispecific antibody, ivonescimab, was presented at the 2024 European Society for Medical Oncology Annual Meeting (ESMO 2024) in Barcelona, Spain, including two presentations and one poster featuring updated ivonescimab data in advanced triple-negative breast cancer (TNBC), recurrent / metastatic head and neck squamous cell carcinoma (HNSCC), and metastatic microsatellite-stable (MSS) colorectal cancer (CRC). Each trial from which the data was generated was a Phase II study conducted in China sponsored by Akeso Inc. (HKEX Code: 9926.HK) with data generated and analyzed by Akeso.
AI Summary
At the 2024 European Society for Medical Oncology Annual Meeting in Barcelona, Summit Therapeutics announced new data on ivonescimab, a novel potential first-in-class bispecific antibody. The updated findings came from two oral presentations and one poster, showcasing Phase II trial results in advanced triple-negative breast cancer (TNBC), recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), and metastatic microsatellite-stable colorectal cancer (CRC). Each study was conducted in China and sponsored by Akeso Inc., with data generated and analyzed by their team. These promising results highlight ivonescimab’s potential beyond its current focus in non-small cell lung cancer by demonstrating encouraging tumor response rates and a manageable safety profile across multiple solid tumor types. Summit plans to use these insights to expand clinical development and further evaluate the benefits of this innovative bispecific antibody in various cancer settings.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- September 8, 2024
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc. announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab.
AI Summary
Summit Therapeutics Inc. shared positive results from the primary analysis of the Phase III HARMONi-2 trial for its novel, potential first-in-class bispecific antibody, ivonescimab. The study compared ivonescimab to pembrolizumab in advanced non-small cell lung cancer (NSCLC) patients with PD-L1 positive tumors. Results showed a median progression-free survival of 11.14 months with ivonescimab versus 5.82 months with pembrolizumab, with benefits observed across different patient subgroups.
Ivonescimab works by targeting both PD-1 and VEGF, which may help it more effectively attack tumors. The manageable safety profile and promising efficacy support further research, including the upcoming Phase III HARMONi-7 trial planned for early 2025.
Read Announcement- Drug:
- Ivonescimab
- Announced Date:
- July 25, 2024
- Indication:
- For Lung cancer
Announcement
Summit Therapeutics Inc announced a strategic five-year collaboration agreement for the purpose of accelerating the development of ivonescimab.
AI Summary
Summit Therapeutics Inc. announced a strategic five-year collaboration with The University of Texas MD Anderson Cancer Center to accelerate the development of ivonescimab. The agreement focuses on using MD Anderson’s clinical expertise and infrastructure to advance ivonescimab, an innovative bispecific antibody that targets PD-1 and VEGF. The collaboration aims to expand the use of this investigational therapy across multiple solid tumors through several new and ongoing clinical trials. Researchers plan to evaluate the safety and potential benefits of ivonescimab while exploring biomarkers and tumor types beyond its current development plan. This joint effort is expected to help speed up clinical development and bring new immunotherapy and anti-angiogenesis treatment options to patients with various cancers, including renal, colorectal, skin, breast cancer, and glioblastoma.
Read Announcement
SMT112 FDA Regulatory Events
SMT112 is a drug developed by Summit Therapeutics for the following indication: Bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SMT112
- Announced Date:
- September 3, 2025
- Indication:
- Bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis
Announcement
Summit Therapeutics Inc presented as part of the Presidential Symposium at the International Association for the Study of Lung Cancer's (IASLC) 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona, Spain.
AI Summary
Summit Therapeutics will host a call on September 8, 2025 at 8:00 ET to discuss data from its global Phase III HARMONi trial of ivonescimab. These results were presented at the Presidential Symposium during IASLC’s WCLC 2025 in Barcelona. A replay on Summit’s website.
HARMONi is a double-blind, placebo-controlled Phase III study comparing ivonescimab plus platinum-doublet chemotherapy to placebo plus chemotherapy. It enrolled patients with EGFR-mutated, advanced non-small cell lung cancer who progressed after a third-generation EGFR TKI.
Ivonescimab is a bispecific antibody that blocks PD-1 and VEGF together. Its four binding sites allow strong, cooperative attachment in tumors, which may improve targeting and safety. It has a six- to seven-day half-life.
Summit completed HARMONi enrollment in 2024 and released results in May 2025. HARMONi is part of Summit’s ivonescimab program in non-small cell lung cancer, including HARMONi-3 and HARMONi-7 trials.
Read Announcement- Drug:
- SMT112
- Announced Date:
- October 3, 2024
- Indication:
- Bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis
Announcement
Summit Therapeutics Inc announced that we have completed enrollment in our HARMONi clinical trial, a multi-regional Phase III study sponsored by Summit evaluating ivonescimab plus platinum-doublet chemotherapy vs.
AI Summary
Summit Therapeutics Inc. announced that enrollment is now complete for its multi-regional Phase III HARMONi clinical trial. This study is the company’s first sponsored global trial evaluating ivonescimab combined with platinum-doublet chemotherapy versus placebo plus platinum-doublet chemotherapy. The trial is focused on patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that have EGFR mutations and who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor. Patients have been enrolled from sites across North America, Europe, and China. The study aims to assess progression-free and overall survival in a patient population where previous Phase III global trials had not shown success with PD-1 monoclonal antibodies. Topline data from the HARMONi trial are expected to be released in mid-2025.
Read Announcement- Drug:
- SMT112
- Announced Date:
- October 3, 2024
- Indication:
- Bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis
Announcement
Summit Therapeutics Inc announced that Topline data from the HARMONi Trial Is Expected in Mid-2025
AI Summary
Summit Therapeutics Inc. announced that it has completed global enrollment for its Phase III HARMONi clinical trial. The study is evaluating the combination of ivonescimab with platinum-doublet chemotherapy versus chemotherapy with placebo, specifically in patients with advanced non-squamous non-small cell lung cancer (NSCLC) that features EGFR mutations. These patients had previously shown disease progression after treatment with a third-generation EGFR tyrosine kinase inhibitor. The trial is being conducted at sites across North America, Europe, and China. Summit expects the topline results from the HARMONi study to be available in mid-2025, which could help determine the potential of ivonescimab to improve treatment outcomes for these patients. The data will be an important milestone in assessing the drug’s benefits for addressing an unmet medical need in this challenging patient population.
Read Announcement
AK112-306 FDA Regulatory Events
AK112-306 is a drug developed by Summit Therapeutics for the following indication: Treatment of Patients with Squamous NSCLC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AK112-306
- Announced Date:
- April 23, 2025
- Indication:
- Treatment of Patients with Squamous NSCLC
Announcement
Summit Therapeutics Inc. announced that the Phase III clinical trial, HARMONi-6 or AK112-306, met its primary endpoint of progression-free survival (PFS).
AI Summary
Summit Therapeutics recently announced that Akeso’s Phase III HARMONi-6 clinical trial (AK112-306) met its primary endpoint of progression-free survival (PFS). The study focused on patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) and evaluated ivonescimab combined with platinum-based chemotherapy compared to tislelizumab plus chemotherapy. Notably, the trial demonstrated a statistically significant improvement in PFS, observed in patients with both PD-L1-positive and PD-L1-negative tumors, marking a significant advancement in treatment over standard anti-PD-(L)1 therapies.
The full data set will be presented at a major upcoming medical conference. Additionally, there were no new safety signals detected during the study, reinforcing the potential of ivonescimab as a promising next-generation treatment option for NSCLC patients.
Read Announcement
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