iTeos and GSK Initiate GALAXIES Lung-301 Phase 3 Study, Assessing Belrestotug and Dostarlimab in Previously Untreated, Unresectable Locally Advanced / Metastatic PD-L1 Selected Non-Small Cell Lung Cancer
iTeos Therapeutics and GSK have commenced the Phase 3 GALAXIES Lung-301 study to evaluate the combination of belrestotug and dostarlimab in untreated, unresectable, locally advanced, or metastatic PD-L1 selected non-small cell lung cancer (NSCLC). This landmark study will enroll approximately 1,000 patients globally, comparing the doublet therapy to a placebo plus pembrolizumab. The study's primary endpoints include progression-free survival and overall survival. Encouraging interim results from the Phase 2 GALAXIES Lung-201 study showed significant tumor reduction and a favorable safety profile with belrestotug and dostarlimab, prompting the initiation of the Phase 3 trial.
- Initiation of a major Phase 3 study with a global reach involving 1,000 patients.
- Promising interim results from Phase 2 showing significant tumor reduction and acceptable safety.
- Potential to establish new benchmarks in the therapeutic regimen for PD-L1 selected NSCLC.
- Primary endpoints focused on critical outcomes: progression-free survival and overall survival.
- The strategic partnership with GSK enhances the study's credibility and resources.
- The study is still in early stages, and final results will not be available for some time.
- Significant investment required for a large-scale, multicenter trial may strain resources.
- Potential risks associated with the efficacy and safety of new drug combinations compared to existing treatments.
- Uncertainty around patient response and potential adverse effects with the new therapeutic regimen.
Insights
The initiation of the Phase 3 study for belrestotug and dostarlimab is a significant milestone in the treatment landscape for non-small cell lung cancer (NSCLC). This trial specifically targets previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC patients, who often have limited options and rely on chemotherapy-free regimens. Belrestotug, in combination with dostarlimab, could present a new therapeutic option, potentially improving progression-free survival and overall survival. The interim results from the Phase 2 study showing clinically meaningful tumor reductions and an acceptable safety profile are promising indicators for this Phase 3 trial. If successful, this combination therapy could set new benchmarks in NSCLC treatment and offer a less toxic alternative to traditional chemotherapy.
This Phase 3 study initiation by iTeos and GSK represents a pivotal moment for both companies. For iTeos, a clinical-stage biopharmaceutical company, moving into Phase 3 signifies progress in their pipeline and could significantly affect their valuation and market perception. The positive interim Phase 2 results provide a solid foundation for investor confidence. However, it’s important to remain cautious as Phase 3 trials are more complex and costly and there is still no guarantee of success. Success in this trial could lead to a substantial increase in share price, potential licensing deals, or even acquisition interest. Conversely, any adverse outcomes could negatively impact stock prices and investor sentiment.
The lung cancer treatment market is highly competitive, with numerous players and established therapies such as pembrolizumab (Keytruda). The novel combination of belrestotug and dostarlimab could potentially capture significant market share, especially if it proves to be more effective or safer than existing treatments. A successful Phase 3 trial would likely position iTeos and GSK favorably in the immuno-oncology market, potentially attracting partnerships and increasing their market footprint. However, investors should consider the competitive landscape, regulatory hurdles and the ability of iTeos and GSK to effectively market and distribute the therapy upon approval.
WATERTOWN, Mass. and GOSSELIES, Belgium, June 17, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, and its development partner GSK, have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC).
“With the initiation of the first Phase 3 study for belrestotug, we are entering a monumental stage in our journey to develop a world-leading oncology company. Nearly
The randomized, double-blind, placebo-controlled, multicenter trial will enroll approximately 1,000 patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC in North America, South America, Europe and Asia. The primary endpoints of the trial are progression free survival and overall survival. In the GALAXIES Lung-301 trial, patients will be randomized 1:1 to either an intravenous infusion of the belrestotug + dostarlimab doublet or placebo + pembrolizumab.
In May 2024, iTeos announced an interim assessment of the Phase 2 GALAXIES Lung-201 study of the belrestotug + dostarlimab doublet in previously untreated, locally advanced, or metastatic PD-L1 selected NSCLC exceeded pre-defined efficacy criteria for clinically relevant activity and showed an acceptable safety profile in line with the TIGIT:PD-1 class. Clinically meaningful tumor reduction was observed at every belrestotug + dostarlimab dose vs dostarlimab monotherapy.
About iTeos Therapeutics, Inc.
iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium.
About Belrestotug (EOS-448/ GSK4428859A)
Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of innate immune responses against cancer. As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC). The therapeutic candidate is progressing in multiple indications in collaboration with GSK.
Internet Posting of Information
iTeos routinely posts information that may be important to investors in the 'Investors' section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos.
Forward-Looking Statements
This press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to our belief that belrestotug + dostarlimab are poised to potentially advance the therapeutic regimen in the first-line PD-L1 high non-small cell lung cancer setting and establish new benchmarks; and our belief that initiating the Phase 3 program with this patient population will serve as the foundation to our broader strategy and building a franchise.
These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos’ control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: success in early clinical trials does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; interim and early data may change as more patient data become available and are subject to audit and verification procedures; the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize due to a variety of reasons, including challenges and uncertainties inherent in product research and development and manufacturing limitations; and those risks identified under the heading “Risk Factors” in iTeos’ Quarterly Report on Form 10-Q for the period ended March 31, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.
Any of the foregoing risks could materially and adversely affect iTeos’ business, results of operations and the trading price of iTeos’ common stock. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law.
For further information, please contact:
Investor Contact:
Carl Mauch
iTeos Therapeutics, Inc.
carl.mauch@iteostherapeutics.com
Media Contact:
media@iteostherapeutics.com
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