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
AK112-306, Ivonescimab, and SMT112. 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.
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
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:
- 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:
- 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- 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
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