Ivonescimab Manuscript for HARMONi-A Clinical Trial Results Published in JAMA
Summit Therapeutics (NASDAQ: SMMT) announced the publication of a manuscript in JAMA detailing the HARMONi-A clinical trial results. The Phase III study, conducted by Akeso in China, investigated ivonescimab combined with chemotherapy in patients with EGFR-mutated non-small cell lung cancer (NSCLC) who had progressed after EGFR TKI treatment. The results indicate that ivonescimab, a PD-1/VEGF bispecific antibody, shows promise in this clinical setting where PD-1 monoclonal antibodies have previously failed.
The study was highlighted in an oral presentation at ASCO 2024 on May 31, 2024. A conference call to discuss the findings will be held on June 3, 2024, at 8:00 AM ET. The call will be webcast live and archived on Summit's website.
- Publication in JAMA enhances credibility and visibility.
- Phase III HARMONi-A study showed promising results for ivonescimab.
- Ivonescimab demonstrated efficacy where other PD-1 monoclonal antibodies failed.
- Highlight at ASCO 2024 boosts exposure and industry recognition.
- Study conducted only in China, potentially limiting generalizability.
- Relies on results generated and analyzed by a third party (Akeso).
- Presentation at ASCO doesn't guarantee regulatory approval or market success.
- Upcoming conference call may reveal additional details impacting investor sentiment.
Insights
Ivonescimab is a promising new therapeutic agent in the non-small cell lung cancer (NSCLC) treatment landscape. The recent publication in the Journal of the American Medical Association (JAMA) of the HARMONi-A clinical trial results highlights the potential of this drug in treating a specific subset of NSCLC patients, those with EGFR mutations who have shown progression after EGFR tyrosine kinase inhibitor (TKI) therapy.
Ivonescimab combines two mechanisms: PD-1 inhibition and VEGF inhibition. This dual mechanism is significant because it targets both the immune evasion and the angiogenesis pathways in cancer, potentially addressing the shortcomings of previous therapies that focused solely on one mechanism. For patients, this could mean not just prolonged survival but also improved quality of life, especially for those who have exhausted other treatment options.
The fact that ivonescimab succeeded where other PD-1 monoclonal antibodies failed may also stimulate further research and investment in bispecific antibodies. It emphasizes the importance of innovative approaches in oncology, where combination therapies are increasingly seen as a way to overcome resistance and improve outcomes.
The publication of the HARMONi-A clinical trial results in a prestigious journal like JAMA is a significant milestone for Summit Therapeutics and its partner, Akeso. From a financial perspective, this publication potentially increases investor confidence and can lead to improved market sentiment for the company's stock. Publication in JAMA also acts as a form of peer validation, demonstrating the scientific community's recognition of the study's rigor and the drug's potential.
Summit Therapeutics' stock (NASDAQ: SMMT) may experience positive movement in the short term due to increased visibility and perceived credibility. However, it's important to consider that while the study results are promising, the drug still needs to navigate through additional regulatory hurdles, including FDA approval. Investors should also keep an eye on the upcoming conference call and any subsequent announcements, as these might provide further insights into the company's plans for this drug's commercialization and potential revenue projections.
In the long term, the success of ivonescimab could lead to significant revenue streams if it is approved and adopted widely in clinical practice. However, the competitive landscape in oncology is intense and the ultimate financial success will depend on the drug's performance in broader, more diverse patient populations and its acceptance by the medical community.
The HARMONi-A trial results published in JAMA represent a important moment for ivonescimab. The trial's design and its focus on a patient population that has seen limited success with prior therapies provide a strong foundation for further research and potential clinical use. The drug's dual mechanism targeting both PD-1 and VEGF pathways introduces a novel approach in NSCLC treatment.
One notable aspect is the trial's setting in China, which means the data might reflect specific patient demographics and healthcare practices prevalent in that region. While this doesn't diminish the results, it does suggest that further studies in more diverse populations would be beneficial to understand the drug's efficacy and safety comprehensively. Additionally, the cooperative binding characteristics of ivonescimab may pave the way for similar future therapies, enhancing the drug development landscape.
Looking forward, the medical community will likely be keenly watching upcoming data releases and peer discussions, such as those at the ASCO conference. These platforms will provide valuable insights into how ivonescimab compares with current standards of care and other emerging therapies in NSCLC.
Publication Entitled: Ivonescimab Plus Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial
HARMONi-A was Featured in Oral Presentation at ASCO 2024 on May 31, 2024
Conference Call to be Held at 8:00am ET on Monday, June 3, 2024
HARMONi-A evaluated ivonescimab combined with platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI) against placebo plus platinum-doublet chemotherapy. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials. The Phase III HARMONi-A study provides further evidence supporting the differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics.
Conference Call
Summit Therapeutics Inc. will host a conference call to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday, June 3, 2024, before the market opens.
Summit will host a live webcast of the conference call at 8:00am ET, which will be accessible through our website www.smmttx.com, and can also be accessed via the following link: https://events.q4inc.com/attendee/130822402.
The dial-in information for US attendees is toll-free at (800) 715-9871. Additionally, all attendees may access through the toll number, (646) 307-1963. The Conference ID is 4259251.
An archived edition of the webcast will be available on our website later in the day on Monday.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories,
This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro.1 This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days,1 is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials, HARMONi and HARMONi-3.
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including
About Lung Cancer
Lung cancer is believed to impact approximately 600,000 people across
About Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in
For more information, please visit https://www.smmttx.com and follow us on X @summitplc.
Summit Forward-looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected use proceeds and uses thereof, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.
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1 Zhong, et al, SITC 2023
2 American Cancer Society: www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed April 2024; World Health Organization: International Agency for Research on Cancer, Globocan data by country (
3 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).
4 About EGFR-Positive Lung Cancer | Navigating EGFR (lungevity.org).
5 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).
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Contact Summit Investor Relations:
Dave Gancarz
Chief Business & Strategy Officer
Nathan LiaBraaten
Senior Director, Investor Relations
Source: Summit Therapeutics Inc.
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