Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision
medicine company transforming the drug discovery process by
combining leading-edge computational and experimental technologies,
today announced complete first-in-human dose escalation data for
RLY-4008, an investigational, potent, selective and oral small
molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2).
These data, from the global Phase 1/2 ReFocus study in patients
with FGFR2-altered cholangiocarcinoma (CCA) and multiple other
solid tumors, will be presented at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting on June 4, 2023. The data
being presented at ASCO are generally consistent with those
previously reported at the European Society for Medical Oncology
(ESMO) Congress in September 2022.
Key Data to be Presented at 2023 ASCO Annual
Meeting
The data that will be presented at the ASCO Annual Meeting are
from the dose escalation portion of the ReFocus study, with a
cut-off date of January 30, 2023. The dose escalation portion of
the study enrolled 116 patients with advanced, FGFR2-altered solid
tumors, the majority of whom have CCA (n=91), and investigated 15
doses, ranging from 20mg to 100mg, across three dose schedules –
once daily (QD), once daily intermittent and twice daily.
The ongoing dose expansion portion of the study includes pivotal
and pivotal-supportive cohorts in CCA patients as well as three
tumor-agnostic cohorts in patients with other tumor types
(non-CCA). Data from the three non-CCA dose expansion cohorts will
be presented in the second half of 2023.
Among the 91 CCA patients in the dose escalation portion of the
study, 25 had FGFR2 fusions and had not previously received an FGFR
inhibitor (FGFRi-naïve FGFR2-fusion CCA). This represents a subset
of the interim data reported at ESMO in September 2022, which also
included some patients from the ongoing dose expansion cohorts.
- Eleven of these patients were
treated at or above the pivotal dose of 70mg QD
- All 11 patients experienced
radiographic tumor reductions
- Eight of the 11 patients (including
all 4 patients receiving the pivotal dose) had a partial response
(73% overall response rate (ORR)), and an additional three patients
experienced a best response of stable disease
- The median duration of response
(DoR) was 11.2 months
- Maximum treatment duration is from a
patient who remains on treatment at 27 months as of the data
cut-off date of January 30, 2023
- Fourteen patients were treated at
doses below the 70mg QD pivotal dose
- Twelve of 14 patients experienced
radiographic tumor reductions
- Five patients experienced a partial
response (36% ORR), and six patients experienced a best response of
stable disease
- Median DoR was 5.6 months
The dose escalation portion of the study also included 50 CCA
patients with FGFR2 fusions who were previously treated with a
non-selective FGFR inhibitor.
- In patients treated at or above
the pivotal dose of 70mg QD (n=14), the ORR was 21 percent, and in
patients treated at doses below the 70mg QD pivotal dose (n=36),
the ORR was 11 percent
- Multiple partial responses
occurred in patients with detected V565 and/or N550 mutations
In addition, across all doses, there were early signs of
activity in the 14 CCA patients with FGFR2 mutations.
- Nine patients experienced
radiographic tumor reductions and four patients experienced a
partial response (29% ORR)
The safety analysis from the complete dose escalation portion of
the study was generally consistent with the analysis from the 2022
ESMO data disclosure, which also included patients treated at the
70mg QD dose in the expansion cohorts:
- Most treatment-related adverse
events were expected FGFR2 on-target, low-grade, monitorable,
generally manageable and largely reversible
- There were no observed Grade 4 or 5
adverse events
- Off-target toxicities of
hyperphosphatemia and diarrhea continued to be clinically
insignificant
The ASCO presentation will be available on the Relay
Therapeutics website under Publications:
https://relaytx.com/publications/ after it is presented on June 4,
2023.
Key Upcoming RLY-4008 Milestones
- Complete enrollment of pivotal
cohort (FGFRi-naïve FGFR2-fusion CCA patients) in the second half
of 2023
- Initial data from non-CCA expansion
cohorts in the second half of 2023
About RLY-4008
RLY-4008 is a potent, selective and oral small molecule
inhibitor of FGFR2, a receptor tyrosine kinase that is frequently
altered in certain cancers. FGFR2 is one of four members of the
FGFR family, a set of closely related proteins with highly similar
protein sequences and properties. Preclinically, RLY-4008
demonstrated FGFR2-dependent killing in cancer cell lines and
induced regression in in vivo models, while minimal inhibition of
other targets was observed, including other members of the FGFR
family. In addition, RLY-4008 demonstrated strong activity against
known clinical on-target resistance mutations in cellular and in
vivo preclinical models. RLY-4008 is currently being evaluated in
ReFocus, a Phase 1/2 study in patients with advanced or metastatic
FGFR2-altered solid tumors with a single arm, potentially
registration-enabling cohort for FGFRi-naïve FGFR2-fusion CCA.
ReFocus Background
RLY-4008 is currently being evaluated in the global ReFocus
Phase 1/2 study in patients with FGFR2-altered CCA and multiple
other solid tumors, including a single arm, potentially
registration-enabling cohort for FGFRi-naïve FGFR2-fusion CCA. The
Phase 1 dose escalation portion of the study has been completed,
and 70mg QD has been selected as the registrational dose. The
expansion cohorts were initiated in December 2021 and now consist
of seven different cohorts based on FGFR2 alteration and tumor
type. Of the seven cohorts, the potential pivotal cohort consists
of approximately 100 previously treated, FGFRi-naïve FGFR2-fusion
CCA patients. To learn more about the ReFocus study, please visit
here.
About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicine
company transforming the drug discovery process by combining
leading-edge computational and experimental technologies with the
goal of bringing life-changing therapies to patients. As the first
of a new breed of biotech created at the intersection of
complementary techniques and technologies, Relay Therapeutics aims
to push the boundaries of what’s possible in drug discovery. Its
Dynamo™ platform integrates an array of leading-edge computational
and experimental approaches designed to drug protein targets that
have previously been intractable or inadequately addressed. Relay
Therapeutics’ initial focus is on enhancing small molecule
therapeutic discovery in targeted oncology and genetic disease
indications. For more information, please visit www.relaytx.com or
follow us on Twitter.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, implied and
express statements regarding the potential therapeutic effects and
anticipated clinical benefits of RLY-4008, including potential
efficacy and tolerability; whether initial clinical results of
RLY-4008 will be predictive of final results in future clinical
trials; Relay Therapeutics’ strategy, business plans and focus; the
progress and timing of updates on the clinical development of and
enrollment for the programs across Relay Therapeutics’ portfolio,
including RLY-4008; and expected therapeutic benefits of its
programs; and Relay Therapeutics’ expectations relating to its
current and future interactions with the U.S. Food and Drug
Administration, including its belief regarding a potential pivotal
cohort. The words “may,” “might,” “will,” “could,” “would,”
“should,” “plan,” “anticipate,” “intend,” “believe,” “expect,”
“estimate,” “seek,” “predict,” “future,” “project,” “potential,”
“continue,” “target” and similar words or expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, risks associated
with: the impact of global economic uncertainty, geopolitical
instability, or public health epidemics or outbreaks of an
infectious disease, such as COVID-19, on countries or regions in
which Relay Therapeutics has operations or does business, as well
as on the timing and anticipated results of its clinical trials,
strategy, future operations and profitability; the delay of any
current or planned clinical trials or the development of Relay
Therapeutics’ drug candidates; the risk that the preliminary
results of its preclinical or clinical trials, including ReFocus,
may not be predictive of future or final results in connection with
future clinical trials of its product candidates; Relay
Therapeutics’ ability to successfully demonstrate the safety and
efficacy of its drug candidates; the timing and outcome of its
planned interactions with regulatory authorities; and obtaining,
maintaining and protecting its intellectual property. These and
other risks and uncertainties are described in greater detail in
the section entitled “Risk Factors” in Relay Therapeutics’ most
recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q, as well as any subsequent filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent Relay Therapeutics' views only as of today and should not
be relied upon as representing its views as of any subsequent date.
Relay Therapeutics explicitly disclaims any obligation to update
any forward-looking statements. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Contact:Megan Goulart617-545-5526
mgoulart@relaytx.com
Media:Dan
Budwick1AB973-271-6085dan@1abmedia.com
Relay Therapeutics (NASDAQ:RLAY)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Relay Therapeutics (NASDAQ:RLAY)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024