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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
 
Date of Report (Date of Earliest Event Reported): May 24, 2024
 
Summit Therapeutics Inc.
(Exact Name of Registrant as Specified in Its Charter)
   
Delaware001-3686637-1979717
(State or Other Jurisdiction
of Incorporation)		(Commission
File Number)		(IRS Employer
Identification No.)
 
601 Brickell Key Drive, Suite 1000, Miami, FL
33131
(Address of Principal Executive Offices)(Zip Code)
 
Registrant’s Telephone Number, Including Area Code: (305) 203-2034
 
Not applicable
(Former Name or Former Address, If Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 
Securities registered pursuant to Section 12(b) of the Act:
Title of Each ClassTrading Symbol(s)Name of Each Exchange on Which Registered
Common stock, $0.01 par value per shareSMMTThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


 

Item 8.01
Other Events.
On May 24, 2024, the National Medical Products Administration (NMPA), the regulatory authority in China responsible for providing marketing authorization for clinical drug candidates, has approved ivonescimab in combination with chemotherapy for use 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).

This is the first approval for ivonescimab by any regulatory authority. The approval for ivonescimab was based on the trial called HARMONi-A (AK112-301), a single region Phase III clinical trial conducted in China comparing ivonescimab plus chemotherapy vs. placebo plus chemotherapy in the aforementioned setting. The trial was sponsored by our partner, Akeso, Inc. (Akeso). Data for this trial was generated and analyzed by Akeso. This data is planned to be released at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting during an oral presentation on Friday, May 31, 2024, scheduled for 4:57pm CT.

On May 23, 2024, ASCO released abstracts for presentations to take place during the Annual Meeting. Included in these abstracts, was topline data associated with HARMONi-A. Notably, patients receiving ivonescimab plus chemotherapy experienced a median progression free survival (PFS) by independent radiology review committee (IRRC) of 7.06 months (95% CI: 5.85 – 8.74) as compared to 4.80 months (95% CI: 4.21 – 5.55) for those patients receiving chemotherapy alone (hazard ratio: 0.46; 95% CI: 0.34 – 0.62).

Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 61.5% patients receiving ivonescimab plus chemotherapy as compared to 49.1% patients receiving chemotherapy; the most common grade ≥3 TEAEs were chemotherapy related adverse events.

Additional data and context including, but not limited to, response rates, stable disease rates, progression free survival, overall survival, and safety is expected to be made available during ASCO’s Annual Meeting.

The abstract can be found here (Abstract 8508): https://meetings.asco.org/2024-asco-annual-meeting/15779?presentation=232409#232409

Ivonescimab is not approved by any regulatory authority in Summit’s license territories, which includes the United States, as well as, Canada, Europe, and Japan.

The approval in China by the NMPA does not change Summit’s current clinical development plan. Summit continues to enroll patients in its two multi-regional Phase III clinical trials in the following indications:
a.ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (“HARMONi”); and
b.ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”).

The approval by the NMPA approval does not affect our ongoing development of the HARMONi and HARMONi-3 trials, nor does it change the timing or requirements of the trial process, or likelihood of approval, for ivonescimab in the United States, or Summit’s other license territories.

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number
Description
104Cover Page Interactive Data File (embedded within the Inline XBRL document)



SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
 SUMMIT THERAPEUTICS INC.
  
  
Date: May 24, 2024By:/s/ Manmeet S. Soni
  Chief Operating Officer and Chief Financial Officer
  (Principal Financial Officer)

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Cover
May 24, 2024
Entity Addresses [Line Items]  
Document Type 8-K
Document Period End Date May 24, 2024
Entity Registrant Name Summit Therapeutics Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-36866
Entity Tax Identification Number 37-1979717
Entity Address, Address Line One 601 Brickell Key Drive, Suite 1000
Entity Address, City or Town Miami
Entity Address, State or Province FL
Entity Address, Postal Zip Code 33131
City Area Code (305)
Local Phone Number 203-2034
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, $0.01 par value per share
Trading Symbol SMMT
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001599298
Amendment Flag false
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