UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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).
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Item 7.01 Regulation FD Disclosure.
On September 7, 2022, a late breaking abstract providing interim clinical data from Relay Therapeutics, Inc.'s (the "Company") ReFocus trial for RLY-4008, a potent, selective and oral small molecule inhibitor of fibroblast growth factor receptor 2 ("FGFR2"), was published on the European Society for Medical Oncology's ("ESMO") website. The abstract has been selected for an oral presentation at the upcoming ESMO Congress 2022, being held both virtually and in Paris, France, from September 9-13, 2022 (the "ESMO Congress"), on September 11, 2022. A copy of the abstract is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The Company plans to issue a press release to announce the results of the interim clinical data presented at the ESMO Congress on September 11, 2022 and intends to host a conference call and live webcast on September 12, 2022 at 8:00 am E.T.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
99.1 |
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Cover Page Interactive Data File (embedded within Inline XBRL document) |
SIGNATURES
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 thereunto duly authorized.
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RELAY THERAPEUTICS, INC. |
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Date: |
September 8, 2022 |
By: |
/s/ Brian Adams |
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Brian Adams, J.D. |
Exhibit 99.1
Hollebecque (ESMO 2022) RLY-4008 LBA
FINAL
Efficacy of RLY-4008, a highly selective FGFR2 inhibitor in patients (pts) with a FGFR2-fusion or rearrangement (f/r), FGFR inhibitor (FGFRi)-naïve cholangiocarcinoma (CCA): ReFocus trial
Antoine Hollebecque1, Mitesh J. Borad2, Lipika Goyal3, Alison M. Schram4, Joon Oh Park5, Philippe Cassier6, Suneel Kamath7, David Tai8, Efrat Dotan9, Richard Kim10, Vaibhav Sahai11 Do-Youn Oh12, Chih-Yi Andy Liao13, Michael Millward14, Desamparados Roda Perez15, Charles Ferté16, Rick Blakesley16, Beni B. Wolf16, Vivek Subbiah17, Robin Kate Kelley 18
1Institut Gustave Roussy, Paris, France; 2 Mayo Cancer Center, Scottsdale, USA; 3Massachusetts General Hospital, Boston, USA; 4Memorial Sloan Kettering Cancer Center, New York, USA; 5Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; 6Centre Léon Berard, Lyon, France; 7The Cleveland Clinic Taussig Cancer Institute, Cleveland, USA; 8National Cancer Centre Singapore, Singapore; 9Fox Chase Cancer Center, Philadelphia, USA; 10H. Lee Moffitt Cancer Center & Research Institute, Tampa, USA; 11The University of Michigan, Ann Arbor, USA; 12Seoul National University Hospital, Seoul, Republic of Korea; 13The University of Chicago, Chicago, USA; 14Linear Clinical Research & University of Western Australia, Nedlands, Australia; 15Hospital Clínico Universitario de Valencia, Spain; 16Relay Therapeutics, Cambridge, USA; 17The University of Texas MD Anderson Cancer Center, Houston, USA; 18UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA
Background
Previous, nonselective FGFRi have validated FGFR2 f/r as a target in CCA by achieving an objective response rate (ORR) of ~20-40% with duration of response (DOR) ~5-9 months. However, off-target toxicity and emergence of polyclonal FGFR2 resistance limit their efficacy. RLY-4008 is the first highly selective, potent FGFR2 inhibitor designed to target both driver alterations and FGFR resistance mutations. Here we present the initial efficacy of RLY-4008 in pts with a FGFR2 f/r, FGFRi-naïve CCA.
Methods
ReFocus (RLY-4008-101), a Phase 1/2 study (NCT04526106), enrolled pts with advanced solid tumors who received RLY-4008 orally (20-200 mg QD or BID). FGFR2 f/r status was determined by local testing. Key objectives were investigator-assessed ORR per RECIST v1.1, DOR, and safety. Safety was analyzed in all dosed pts and efficacy in pts with FGFR2 f/r, FGFRi-naïve CCA with measurable disease and an opportunity for ≥2 tumor assessments to confirm response.
Results
As of 01AUG22, 38 pts with FGFR2 f/r, FGFRi naïve CCA were efficacy evaluable. Most pts received the recommended phase 2 dose (RP2D); most (68%) remain on treatment with median duration of 6 months (<0.1 - 18.5 months). Potent efficacy was observed across all doses, particularly at the RP2D with an ORR of 88% (Table). One pt treated at the RP2D had a near-complete response and subsequent tumor resection with curative intent. DOR is not yet mature, with majority of responses ongoing. Across all doses (N=195), the most common treatment-related AEs (TRAEs) were low-grade stomatitis (48%), PPE (46%), and dry mouth (31%). No grade 4/5 TRAEs were observed.
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RP2D (70 mg QD) N=17 |
All dose levels N=38 |
ORR, n (% [95% CI]) |
15 (88.2 [63.6 - 98.5]) |
24 (63.2 [46.0 - 78.2]) |
Confirmed ORR, n (% [95% CI]) |
14 (82.4 [56.6 - 96.2]) |
22 (57.9 [40.8 - 73.7]) |
Response ongoing, n/N (%) |
15/15 (100.0) |
19/24 (79.2) |
Disease control rate, n (%) |
17 (100.0) |
36 (94.7) |
Remain on treatment, n (%) |
15 (88.2) |
26 (68.4) |
Conclusions
RLY-4008 is a promising next-generation inhibitor with potential to transform the treatment of FGFR2 f/r, FGFRi- naïve CCA. Pivotal testing continues in ReFocus.