0001599298
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0001599298
2024-05-24
2024-05-24
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)
Delaware 001-36866 37-1979717
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
601 Brickell Key Drive, Suite 1000 33131
,
Miami
,
FL
(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 Class Trading Symbol(s) Name of Each Exchange on Which Registered
Common stock, $0.01 par value per share SMMT The 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 ((s)230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 ((s)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.
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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 e3 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 e3 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-a
sco-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
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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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, 2024 By: /s/ Manmeet S. Soni
Chief Operating Officer and Chief Financial Officer
(Principal Financial Officer)
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