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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
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Date of Report (Date of earliest event reported): September 14, 2024 |
iTeos Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39401 |
84-3365066 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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321 Arsenal Street |
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Watertown , Massachusetts |
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02472 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 339 217 0161 |
(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:
☐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:
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Title of each class
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Trading
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Name of each exchange on which registered
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Common Stock, $0.001 par value per share |
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ITOS |
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The Nasdaq Global Market |
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 7.01 Regulation FD Disclosure.
On September 14, 2024, iTeos Therapeutics, Inc. (the "Company") issued a press release announcing additional interim clinical data from GALAXIES Lung-201, the Phase 2 platform study sponsored by the Company’s development partner GSK plc, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer, a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. The Company will host a conference call to discuss the interim clinical data on September 16, 2024 at 8:00 a.m. E.T. A copy of the slide presentation that will accompany the call is being furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibits 99.1 or 99.2.
The information in this Item 7.01 is furnished pursuant to Item 7.01 and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.
Item 9.01 Financial Statements and Exhibits.
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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iTeos Therapeutics, Inc. |
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Date: |
September 16, 2024 |
By: |
/s/ Michel Detheux |
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Michel Detheux, Ph.D.
President and Chief Executive Officer |
iTeos Announces Clinically Meaningful Objective Response Rate Observed at Every Dose in Follow-up Interim Analysis of GALAXIES Lung-201 Study of Belrestotug + Dostarlimab in First-Line, PD-L1 High Non-Small Cell Lung Cancer Patients
- Clinically meaningful objective response rate (ORR) of 63.3-76.7% observed with belrestotug + dostarlimab combinations, with confirmed ORR (cORR) at ~60% for every dose
- >30% cORR difference between belrestotug + dostarlimab vs dostarlimab monotherapy
- Belrestotug + dostarlimab safety profile broadly consistent with known safety profile of checkpoint inhibitor combinations
- GALAXIES Lung-301, global Phase 3 registration study, enrolling in same indication and setting
- iTeos to host a conference call on Monday, September 16, 2024 at 8:00am ET
WATERTOWN, Mass. and GOSSELIES, Belgium, September 14, 2024 -- 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, today announced follow-up interim data from GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC).
“We are encouraged by this interim cut of GALAXIES Lung-201 data in which a clinically meaningful, investigator-assessed Objective Response Rate was observed with belrestotug in combination with dostarlimab in first-line, PD-L1 high non-small cell lung cancer patients. Further, with roughly 60 percent confirmed ORR at three distinct doses and a meaningful difference of 30 percent compared to dostarlimab alone, we believe this underscores the potential differentiation of our TIGIT:PD-1 doublet,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “The improvement in depth of response in tumor measurement in patients treated with the doublet compared to those treated with PD-1 alone holds promising therapeutic potential for a patient population with limited options. We believe these encouraging data further support the recent initiation of GALAXIES Lung-301, the registrational Phase 3 trial assessing the TIGIT:PD-1 doublet in the same indication and setting. Based on these results, we are committed to leveraging our science to impact the lives of people living with cancer and are excited to see longer-term follow-up data in 2025.”
“While checkpoint inhibitor therapies have played a significant role in how we treat non-small cell lung cancer, the medical community continues to look for new patient-centered treatment options to meaningfully improve this life-threatening condition,” said Brian Henick, M.D., interim director of experimental therapeutics and director of translational research in upper-aerodigestive malignancies in medical oncology of Columbia University Irving Medical Center. “The follow-up interim analysis from the GALAXIES Lung-201 study represent promising progress and the deep responses observed in the belrestotug + dostarlimab doublet provide a strong, consistent signal.
We eagerly anticipate gaining further insights from this trial over the next year as the dataset matures.”
Highlights of Interim GALAXIES Lung-201 Data
As of the June 7, 2024 data cutoff, the late-breaking interim data presented at the ESMO Congress were based on 124 patients eligible for safety and efficacy evaluation (modified intention-to-treat ≥5.6 months follow-up). Patients received dostarlimab or belrestotug + dostarlimab at the following dose levels: dostarlimab 500mg, belrestotug 100mg + dostarlimab 500mg (Dose A), belrestotug 400mg + dostarlimab 500mg (Dose B), and belrestotug 1000mg + dostarlimab 500mg (Dose C).
•Clinically meaningful improvement in the primary endpoint of ORR was observed consistently across each belrestotug + dostarlimab cohort (63.3% Dose A, 65.6% Dose B and 76.7% Dose C compared to 37.5% with dostarlimab alone). cORR, defined as complete or partial response confirmed by repeat imaging ≥4 weeks after response criteria first met, was roughly 60.0% for each dose compared to 28.1% cORR for dostarlimab alone.
•Of the patients with evaluable paired ctDNA samples (baseline and week 7), median ctDNA reduction was 65% for dostarlimab monotherapy compared to 55% for Dose A, 94% for Dose B, and 97% for Dose C.
•Belrestotug + dostarlimab led to an increase in immune-related adverse events compared to dostarlimab monotherapy, which were generally manageable. The safety profile of belrestotug in combination with dostarlimab has been broadly consistent with the known safety profile of combination therapy with checkpoint inhibitors. The most frequent treatment-related adverse events (≥15%) were skin and subcutaneous tissue disorders (50%) and endocrine disorders (26%), both commonly observed with immunotherapies.
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Response measure in mITT |
Dostarlimab (N=32) |
Dose A: Dostarlimab +
belrestotug 100 mg (N=30) |
Dose B: Dostarlimab +
belrestotug 400 mg (N=32) |
Dose C: Dostarimab +
belrestotug 1000 mg (N=30) |
Median follow-up, months (range) |
7.0 (0.2–16.6) |
8.5 (0.3–14.3) |
8.5 (0.4–16.2) |
6.7 (2.4–9.7) |
ORR,1,2%
n (95% CI) |
37.5% n=12 (21.1–56.3) |
63.3%
n=19 (43.9–80.1) |
65.6%
n=21 (46.8–81.4) |
76.7%
n=23 (57.7–90.1) |
Complete response, n (%) |
0 |
0 |
0 |
0 |
Partial response, n (%) |
12 (37.5%) |
19 (63.3%) |
21 (65.6%) |
23 (76.7%) |
Stable disease, n (%) |
14 (43.8%) |
5 (16.7%) |
4 (12.5%) |
5 (16.7%) |
Progressive disease, n (%) |
2 (6.3%) |
4 (13.3%) |
3 (9.4%) |
2 (6.7%) |
Not evaluable/no assessment,3 n (%) |
4 (12.5%) |
2 (6.7%) |
4 (12.5%) |
0 |
Confirmed ORR,2 %
n (95% CI) |
28.1%
n=9 (13.7–46.7) |
60.0%
n=18 (40.6–77.3) |
59.4%
n=19 (40.6–76.3) |
63.3%
n=19 (43.9–80.1) |
1. unconfirmed ORR; 2. PD-L1 high (TPS ≥50%) was determined locally or centrally by DAKO 22C3 or VENTANA SP263 assay; 3. patients who only had "not evaluable" post baseline assessments, those who had a best response of "not evaluable" per RECIST 1.1 criteria, or those where no post-baseline tumor assessment was performed; CI, confidence interval
Conference Call Details
The follow-up interim data from GALAXIES Lung-201 will be discussed during a conference call and webcast presentation on Monday, September 16th, 2024 at 8:00AM ET. To register for the webcast presentation, please visit the Events section on the Investors page of the iTeos website
at investors.iteostherapeutics.com. A webcast replay may be accessed on the Investors section of the iTeos website.
Phase 2 GALAXIES Lung-201 Trial Design
The Phase 2 GALAXIES Lung-201 study is a randomized, open-label, global platform study evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with PD-L1 high (TPS ≥50%), previously untreated, unresectable, locally advanced or metastatic NSCLC. Arms and interventions in this study include: pembrolizumab (anti-PD-1) monotherapy, dostarlimab (anti-PD-1) monotherapy, belrestotug (anti-TIGIT) + dostarlimab doublet combination, and belrestotug + dostarlimab + nelistotug (anti-CD96) triplet combination.
The primary endpoint of the study is investigator-assessed ORR per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary endpoints include safety and additional efficacy measures such as progression free survival, overall survival, and duration of response.
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 and adaptive 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 the potential benefits of belrestotug and the potential differentiation of belrestotug + dostarlimab; belrestotug’s market opportunity; and our plans and
expected milestones, including having longer-term follow-up data from GALAXIES Lung-201 in 2025.
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 preclinical testing and 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 data for our product candidates may not be sufficient for obtaining regulatory approval to move into later stage trials or to commercialize products; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos’ control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, negative developments in the field of immuno-oncology, such as adverse events or disappointing results, including in connection with competitor therapies, and regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in iTeos’ Annual Report on Form 10-Q for the period ended June 30, 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
Cancer Immunotherapies by design™ GALAXIES Lung-201 Update ESMO 2024
Forward-Looking Statements This presentation 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 the potential benefits of belrestotug and the potential differentiation of belrestotug + dostarlimab; belrestotug’s market opportunity; our plans and expected milestones, including having longer-term follow-up data from GALAXIES Lung-201 in 2025 and having data from the Phase 2 TIG-006 and GALAXIES H&N-202 in 2025; and our expectation to have cash runway through 2027. 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 preclinical testing and 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 data for our product candidates may not be sufficient for obtaining regulatory approval to move into later stage trials or to commercialize products; iTeos may encounter unanticipated costs or may expend cash more rapidly or more slowly than currently anticipated due to challenges and uncertainties inherent in product research and development and biologics manufacturing; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos’ control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, negative developments in the field of immuno-oncology, such as adverse events or disappointing results, including in connection with competitor therapies, and regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in iTeos’ Annual Report on Form 10-Q for the period ended June 30, 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. Statements regarding the Company’s cash runway do not indicate when or if the Company may access the capital markets. 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.
Introduction Michel Detheux, PhD Chief Executive Officer & President
Next Steps GALAXIES Lung-201: Longer-term follow-up data in 2025 GALAXIES Lung-301: Enrolling GALAXIES Lung-201Follow-up Interim Analysis Study Scope Population: Unresectable locally advanced/metastatic PD-L1 high 1L NSCLC Primary Endpoint: ORR1 per RECIST 1.1 by investigator assessment Follow-Up Interim Data: Clinically meaningful anti-tumor activity by belrestotug + dostarlimab at all doses vs dostarlimab monotherapy Key Observations Belrestotug + dostarlimab combinations observed clinically meaningful ORR of 63.3-76.7%, with cORR at ~60% for every dose >30% cORR difference between belrestotug + dostarlimab vs dostarlimab monotherapy Belrestotug + dostarlimab safety profile broadly consistent with known safety profile of checkpoint inhibitor combinations Numerically greater reduction of ctDNA associated with belrestotug 400mg and 100mg + dostarlimab cohorts 1. Unconfirmed; NSCLC, non-small cell lung cancer; Q3W, every 3 weeks; ORR, objective response rate; coRR, confirmed objective response rate; RECIST, Response Evaluation Criteria in Solid Tumours; PFS, progression free survival; AE, adverse event Outcomes And Actions
Belrestotug: Designed to Enhance the Anti-Tumor Response through Activation of Multiple Immune Cells NK Cell Cancer Cell Belrestotug FCg R T Cell CD112 CD155 CD112 CD155 TIGIT CD226 TIGIT CD226 DC NK cell MACROPHAGE FCg R FCg R Treg and exhausted T cells TIGIThigh 1 Binding to TIGIT Optimized affinity and potency to inhibit the suppressive function of TIGIT and to activate T cell and NK cell killing of tumor cells 2 Binding to FcgR Pro-inflammatory cytokine release and activation of antigen-presenting cells (DCs and macrophages) Depletion of Tregs and exhausted T cells allows for enhanced anti-tumor response Tumor cell Killing Pro-inflammatory cytokines Belrestotug Cancer Cell NK Cell T Cell DC, dendritic cell; NK, natural killer; Tregs, regulatory T cells
Belrestotug: The First And Only TIGIT to Demonstrate Robust Target Engagement iTeos AACR 2021 doi: 10.1136/jitc-2022-SITC2022.0768 doi: 10.1038/s41586-024-07121-9 *Merck vibostolimab has yet to publicly show Treg depletion data; Arcus’ domvanalimab is an Fc silent TIGIT and not capable of Treg depletion Fc Silent* Undisclosed* 100% 20-30%2 Mild Treg depletion3 Unique Epitope Binding High Affinity + Potency First and only TIGIT with proven Treg depletion at all doses1 Only TIGIT to Demonstrate Phase 1 Monotherapy Activity1 80%
GALAXIES Lung-201 Follow-Up Interim Analysis David Feltquate, MD Chief Medical Officer
GALAXIES Lung-201 - Phase 2 in 1L NSCLC Status Enrolling Masking Open label PDL1 Expression ≥50% Lines of Therapy No prior systemic therapy Delivery IV Infusion Study Design Objectives Evaluate belrestotug + dostarlimab safety, efficacy, PK/PD Primary Endpoint ORR Secondary Endpoint PFS, OS, DOR Clinical Trials Listing NCT05565378 The largest TIGIT Phase 2 in PD-L1 high 1L NSCLC NSCLC, non-small cell lung cancer; Q3W, every 3 weeks; ORR, overall response rate; PFS, progression free survival; OS, overall survival; DOR, duration of response LUNG-201 Estimated Enrollment 300 R Key R Subjects Randomization Dostarlimab + Belrestotug + Nelistotug (CD96) Pembrolizumab 200mg Q3W Dostarlimab 500mg Q3W Dostarlimab 500mg + Belrestotug 100mg Q3W (Dose A) Dostarlimab 500mg + Belrestotug 400mg Q3W (Dose B) Dostarlimab 500mg + Belrestotug 1000mg Q3W (Dose C)
Characteristic, n (%) Dostarlimab N=32 A: Belrestotug 100 mg + dostarlimab N=30 B: Belrestotug 400 mg + dostarlimab N=32 C: Belrestotug 1000 mg + dostarlimab N=30 Male 26 (81%) 18 (60%) 26 (81%) 16 (53%) Years of age, median (range) 69.0 (37–86) 68.5 (45–79) 67.0 (50–78) 68.0 (47–83) Race White 24 (75%) 17 (61%) 18 (58%) 19 (70%) Asian 5 (16%) 7 (25%) 10 (32%) 6 (22%) ECOG PS1 1, n (%) 11 (34%) 20 (67%) 16 (50%) 18 (60%) Stage III1 4 (12.5%) 7 (23.3%) 5 (15.6%) 3 (10%) Stage IVa1 18 (56%) 8 (27%) 12 (38%) 17 (57%) Stage IVb1 10 (31%) 15 (50%) 15 (47%) 10 (33%) Squamous2 11 (34%) 11 (37%) 13 (41%) 9 (30%) PD-L1 TPS ≥50%3 32 (100%) 30 (100%) 32 (100%) 29 (97%)4 Central PD-L1 TPS ≥90%5 12 (38%) 11 (37%) 12 (38%) 11 (37%) Metastases at baseline Bone 5 (16%) 7 (23%) 5 (16%) 4 (13%) Brain 3 (9%) 4 (13%) 3 (9%) 3 (10%) Liver 3 (9%) 6 (20%) 3 (9%) 0 Baseline Characteristics Were Balanced Across Arms, with a Few Notable Differences in TIGIT:PD-1 Doublet Arms 1At screening; 2stratification factor; 3PD-L1 high (TPS ≥50%) was determined locally or centrally by DAKO 22C3 or VENTANA SP263 assay; 4one patient was enrolled with a PD-L1 <50%, a protocol deviation was noted; 5PD-L1 TPS ≥90% was determined centrally using the VENTANA SP263 assay. ECOG PS, Eastern Cooperative Oncology Group performance status; PD-L1, programmed death ligand-1; TPS, tumour positive score.
Response measure in mITT Dostarlimab N=32 A: Belrestotug 100 mg + dostarlimab N=30 B: Belrestotug 400 mg + dostarlimab N=32 C: Belrestotug 1000 mg + dostarlimab N=30 Median follow-up, months (range)1 7.0 (0.2–16.6) 8.5 (0.3–14.3) 8.5 (0.4–16.2) 6.7 (2.4–9.7) ORR,2,3 % n (95% CI) 37.5% n=12 (21.1–56.3) 63.3% n=19 (43.9–80.1) 65.6% n=21 (46.8–81.4) 76.7% n=23 (57.7–90.1) Complete response, n (%) 0 0 0 0 Partial response, n (%) 12 (37.5%) 19 (63.3%) 21 (65.6%) 23 (76.7%) Stable disease, n (%) 14 (43.8%) 5 (16.7%) 4 (12.5%) 5 (16.7%) Progressive disease, n (%) 2 (6.3%) 4 (13.3%) 3 (9.4%) 2 (6.7%) Not evaluable/no assessment,4 n (%) 4 (12.5%) 2 (6.7%) 4 (12.5%) 0 Confirmed ORR,3,5 % n (95% CI) 28.1% n=9 (13.7–46.7) 60.0% n=18 (40.6–77.3) 59.4% n=19 (40.6–76.3) 63.3% n=19 (43.9–80.1) Clinically Meaningful ORR Observed at Every Dose vs Dostarlimab Monotherapy 1As of data cut 7 Jun 2024, 65% of patients remained in ongoing follow-up; 2unconfirmed ORR; 3PD-L1 high (TPS ≥50%) was determined locally or centrally by DAKO 22C3 or VENTANA SP263 assay; 4patients who only had "not evaluable" post-baseline assessments, those who had a best response of "not evaluable" per RECIST 1.1 by investigator assessment, or those where no post-baseline tumour assessment was performed; 5complete or partial response confirmed by repeat imaging ≥4 weeks after response criteria first met. CI, confidence interval; mITT, modified intention-to-treat; ORR, objective response rate; PD-L1, programmed death ligand-1; RECIST, Response Evaluation Criteria in Solid Tumours; TPS, tumour positive score.
Belrestotug + Dostarlimab Consistently Increased Depth of Response vs Dostarlimab Monotherapy Best Observed Response (Without Confirmation): PR SD PD 100 90 80 70 60 50 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 Maximum percentage change from baseline1 2 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Patients Dostarlimab (N=32) SD PD SD SD SD SD SD SD SD SD SD SD SD PD SD SD PR PR PR PR PR PR PR PR PR PR PR PR 100 90 80 70 60 50 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 Maximum percentage change from baseline1 2 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Patients A: Belrestotug 100 mg + dostarlimab (N=30) PD PD PD PD SD SD SD SD PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR SD 100 90 80 70 60 50 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 Maximum percentage change from baseline1 2 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Patients B: Belrestotug 400 mg + dostarlimab (N=32) PD PD PD SD SD SD SD PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR 100 90 80 70 60 50 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 Maximum percentage change from baseline1 2 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 30 Patients C: Belrestotug 1000 mg + dostarlimab (N=30) PD PD SD SD SD SD SD PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR PR 28 29 PR PR 1Numerically lowest percent change from baseline that is on or prior to date of first radiological PD and start of follow-up anticancer therapy (excluding radiotherapy and surgery); patients without assessable post-baseline scans or where all baseline target lesions are not measured at subsequent visits are not included in figure; responses shown are per RECIST 1.1 by investigator assessment without confirmation. PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; SD, stable disease.
Consistent Deep Tumor Reduction with Ongoing Responses by Belrestotug + Dostarlimab vs Dostarlimab Monotherapy Ongoing – in follow-up Died Ongoing – on study treatment Withdrawn 1Investigator assessed percentage change from baseline per RECIST 1.1 by investigator assessment. RECIST, Response Evaluation Criteria in Solid Tumors. 32 Days 64 96 128 160 192 224 256 288 320 352 384 416 448 Dostarlimab (N=32) 80 60 40 20 0 -20 -40 -60 -80 -100 0 Percentage change from baseline1 32 Days 64 96 128 160 192 224 256 288 320 352 384 416 448 B: Belrestotug 400 mg + dostarlimab (N=32) 80 60 40 20 0 -20 -40 -60 -80 -100 0 Percentage change from baseline1 32 Days 64 96 128 160 192 224 256 288 320 352 384 416 448 A: Belrestotug 100 mg + dostarlimab (N=30) 80 60 40 20 0 -20 -40 -60 -80 -100 0 Percentage change from baseline1 32 Days 64 96 128 160 192 224 256 288 320 352 384 416 448 C: Belrestotug 1000 mg + dostarlimab (N=30) 80 60 40 20 0 -20 -40 -60 -80 -100 0 Percentage change from baseline1
Numerically Greater Reduction of ctDNA Associated with Belrestotug 400mg and 1000mg + Dostarlimab Cohorts 1000 700 500 300 200 100 0 -50 -80 -90 -95 -98 -100 ctDNA % change at Week 71 Dostarlimab (N=19) A: Belrestotug 100 mg + dostarlimab (N=18) B: Belrestotug 400 mg + dostarlimab (N=22) C: Belrestotug 1000 mg + dostarlimab (N=20) Kruskal-Wallis, p=0.073 Molecular response threshold2 1Mean variant allele frequency change from baseline to Week 7; 2molecular response threshold defined as having at least 50% reduction of ctDNA levels. Responses shown are per RECIST 1.1 by investigator assessment without confirmation. ctDNA, circulating tumour DNA; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; SD, stable disease. Best Observed Response (Without Confirmation): PR SD PD Molecular Response Rate (>-50% from Baseline) Median ctDNA % Change -65% 11/19 (58%) -55% 9/18 (50%) -94% 15/22 (68%) -97% 18/20 (90%)
Belrestotug + Dostarlimab Is Broadly Consistent with Known Safety Profile of Checkpoint Inhibitor Combinations Increase in immune-related adverse events with belrestotug + dostarlimab vs dostarlimab Event, n (%) Dostarlimab (N=32) A: Belrestotug 100 mg + dostarlimab (N=30) B: Belrestotug 400 mg + dostarlimab (N=32) C: Belrestotug 1000 mg + dostarlimab (N=30) TEAE 29 (91%) 29 (97%) 31 (97%) 30 (100%) Grade 3+ TEAE 14 (44%) 19 (63%) 16 (50%) 16 (53%) TRAE 19 (59%) 24 (80%) 27 (84%) 29 (97%) Grade 3+ TRAE 5 (16%) 10 (33%) 7 (22%) 13 (43%) Serious TRAE 3 (9%) 10 (33%) 8 (25%) 11 (37%) Grade 5 serious TRAE 0 2 (7%) 1 (3%) 0 TRAE leading to discontinuation 2 (6%) 7 (23%) 5 (16%) 12 (40%) Grade 1/2 TR-irAE leading to discontinuation 0 (0%) 2 (7%) 3 (10%) 2 (7%) TR-irAE1 6 (19%) 20 (67%) 18 (56%) 22 (73%) Grade 3+ TR-irAE 4 (13%) 9 (30%) 5 (16%) 11 (37%) Infusion-related reactions2 4 (13%) 8 (27%) 3 (9%) 7 (23%) The most common TRAEs overall (≥15%) were skin and subcutaneous tissue disorders (50%) and endocrine disorders (26%) The most common TEAEs leading to discontinuation were skin and subcutaneous tissue disorders (6%) and respiratory, thoracic and mediastinal disorders (6%) Fatal serious TRAEs include immune-mediated pneumonitis (N=1), immune-mediated hepatitis (N=1) and immune-mediated myocarditis (N=1) 1Immune-related AEs are events of potential immunologic aetiology, including irAEs; irAEs are identified as any Grade 2+ AEs (or AEs of unknown grade) based on a prespecified search list of preferred terms using the most recent MedDRA version identified by a custom MedDRA query (CMQ) using GSK Terms of Interest codes; 2infusion-related reactions are drug component–related AEs which occurred ≤1 day after drug component infusion and are identified based on a prespecified search list of preferred terms and most recent MedDRA version. AE, adverse event; irAE, immune-related AE; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event; TR, treatment-related; TRAE, treatment-related treatment-emergent adverse event.
Belrestotug + Dostarlimab Is Broadly Consistent with Known Safety Profile of Checkpoint Inhibitor Combinations Most common TR-irAE were skin and subcutaneous tissue disorders The majority of Grade 2+ irAEs were skin and subcutaneous tissue disorders across all combination cohorts and were considered generally manageable with steroids (topical or oral). Adaptions to skin toxicity management are ongoing. Immune-mediated lung disease and myocarditis were more frequent in the belrestotug 1000 mg + dostarlimab cohort 1Immune-related AEs are events of potential immunologic aetiology, including irAEs; irAEs are identified as any Grade 2+ AEs (or AEs of unknown grade) based on a prespecified search list of preferred terms using the most recent MedDRA version identified by a custom MedDRA query (CMQ) using GSK Terms of Interest codes; 2infusion-related reactions are drug component–related AEs which occurred ≤1 day after drug component infusion and are identified based on a prespecified search list of preferred terms and most recent MedDRA version. AE, adverse event; irAE, immune-related AE; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event; TR, treatment-related; TRAE, treatment-related treatment-emergent adverse event. Event, n (%) Dostarlimab N=32 A: Belrestotug 100 mg + dostarlimab (N=30) B: Belrestotug 400 mg + dostarlimab (N=32) C: Belrestotug 1000 mg + dostarlimab (N=30) TR-irAE1 by preferred terms (≥10% incidence in any cohort2), Grade 2+ Grade 3+ Immune-mediated dermatitis 0 0 5 (17%) 1 (3%) 0 0 6 (20%) 3 (10%) Pruritus 0 0 3 (10%) 0 5 (16%) 0 4 (13%) 0 Rash 0 0 2 (7%) 0 4 (13%) 0 2 (7%) 1 (3%) Immune-mediated hypothyroidism 1 (3%) 0 1 (3%) 0 3 (9%) 0 4 (13%) 0 ALT increase 1 (3%) 1 (3%) 3 (10%) 2 (7%) 0 0 1 (3%) 1 (3%) Immune-mediated lung disease 0 0 1 (3%) 0 1 (3%) 0 3 (10%) 1 (3%) Immune-mediated myocarditis 0 0 1 (3%) 1 (3%) 0 0 3 (10%) 1 (3%)
Closing Remarks Michel Detheux, PhD Chief Executive Officer & President
GALAXIES Lung-301 - Phase 3 in 1L NSCLC Status Enrolling Masking Double-blind PDL1 Expression ≥50% Lines of Therapy No prior systemic therapy Delivery IV Infusion Study Design Objectives Evaluate belrestotug + dostarlimab safety, efficacy vs placebo + pembrolizumab Primary Endpoint PFS, OS Secondary Endpoint ORR, MRR, DOR Dostarlimab + Belrestotug Pembrolizumab + Placebo NSCLC, non-small cell lung cancer; PFS, progression free survival; OS, overall survival; ORR, overall response rate; MRR, molecular response rate; DOR, duration of response LUNG-301 Estimated Enrollment 1,000 Key R Subjects Randomization R
Deep Responses with Generally Manageable Safety Profile Observed with Belrestotug + Dostarlimab ~60% cORR at every dose of belrestotug + dostarlimab vs ~28% for dostarlimab Generally Manageable IRAEs Belrestotug + dostarlimab safety profile broadly consistent with IO combinations Numerically Greater ctDNA Reduction Observed by belrestotug 400mg and 1000mg + dostarlimab cohorts vs dostarlimab >30% cORR difference observed at every dose of belrestotug + dostarlimab vs dostarlimab Next Steps GALAXIES Lung-201: Longer-term follow-up data in 2025 GALAXIES Lung-301: Enrolling
Upcoming TIGIT 2024 + 2025 Catalyst Calendar *Pro forma cash, cash equivalents and short-term investments NSCLC, non-small cell lung cancer; HNSCC, head and neck squamous cell carcinoma; ENT1, Equilibrative Nucleoside Transporter 1; MoA, Mechanism of Action ~$714M As of June 30, 2024 Runway through 2027 Pro forma cash, cash equivalents and short-term investments Funded Through Significant Milestones 2024 1L NSCLC (Phase 2 GALAXIES LUNG-201 - ORR) 1L HNSCC (Phase 2 TIG-006 + GALAXIES H&N-202 data) 1L NSCLC (Phase 2 GALAXIES LUNG-201) 2025
Cancer Immunotherapies by design™ Nasdaq: ITOS September 2024
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