This section highlights FDA-related milestones and regulatory updates for drugs developed by iTeos Therapeutics (ITOS).
Over the past two years, iTeos Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
A2A-005, EOS-215, Lung-201, and Lung-301. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
A2A-005 - FDA Regulatory Timeline and Events
A2A-005 is a drug developed by iTeos Therapeutics for the following indication: For (NSCLC) patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- A2A-005
- Announced Date:
- December 12, 2024
- Indication:
- For (NSCLC) patients
Announcement
iTeos Therapeutics, Inc announced the presentation of clinical, translational, and preclinical data from its adenosine A2A receptor (A2AR) antagonist program, inupadenant, including interim data from the dose escalation portion of A2A-005, the Phase 2 trial assessing inupadenant and platinum-doublet chemotherapy in post-immunotherapy metastatic non-small cell lung cancer (NSCLC) patients, at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2024.
AI Summary
iTeos Therapeutics recently presented new clinical, translational, and preclinical data on its investigational adenosine A2A receptor antagonist, inupadenant, at the European Society for Medical Oncology Immuno-Oncology Congress 2024. The data included interim results from the dose escalation portion of the Phase 2 A2A-005 trial. In this trial, post-immunotherapy patients with metastatic non-small cell lung cancer received inupadenant in combination with platinum-doublet chemotherapy. Early findings showed a high overall response rate, with the recommended Phase 2 dose exhibiting particularly promising results. Importantly, the safety profile was manageable, as no dose-related toxicities were observed. These results highlight the company’s dedication to targeting the adenosine pathway—a key mechanism in tumor immunosuppression—with the aim of improving outcomes for cancer patients.
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EOS-215 - FDA Regulatory Timeline and Events
EOS-215 is a drug developed by iTeos Therapeutics for the following indication: For the tumor microenvironment and overcome resistance.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EOS-215
- Announced Date:
- March 25, 2025
- Indication:
- For the tumor microenvironment and overcome resistance
Announcement
iTeos Therapeutics, Inc announced the poster presentations of preclinical data on EOS-215, a potential best-in-class antibody targeting TREM2, and a novel small molecule inhibiting PTPN1/2 at the American Association for Cancer Research (AACR) Annual Meeting, being held April 25-30, 2025 in Chicago, Illinois.
AI Summary
iTeos Therapeutics announced it will present preclinical data for two promising oncology treatments at the American Association for Cancer Research Annual Meeting in Chicago, Illinois, from April 25-30, 2025. One presentation features EOS-215, a potential best-in-class antibody targeting TREM2. EOS-215 is designed to reprogram the tumor microenvironment by blocking TREM2, which may help turn off tumor-supporting activities of certain immune cells and activate T cells to fight cancer more effectively.
The other poster will present data on a novel small molecule that inhibits PTPN1/2. By targeting these enzymes, the small molecule aims to enhance the antitumor response and improve cytokine signaling, ultimately reshaping the tumor environment to boost immune activity. These early results showcase iTeos' commitment to pioneering new immuno-oncology strategies and could pave the way for innovative cancer therapies.
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Lung-201 - FDA Regulatory Timeline and Events
Lung-201 is a drug developed by iTeos Therapeutics for the following indication: In Patients (pts) With Previously Untreated Locally Advanced/Metastatic (LA/M) PD-L1 High (TPS >/=50%) Non-Small Cell Lung Cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lung-201
- Announced Date:
- May 13, 2025
- Indication:
- In Patients (pts) With Previously Untreated Locally Advanced/Metastatic (LA/M) PD-L1 High (TPS >/=50%) Non-Small Cell Lung Cancer (NSCLC)
Announcement
iTeos Therapeutics, Inc. today reported topline results from an updated interim analysis of 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).
AI Summary
iTeos Therapeutics recently reported topline interim results from the GALAXIES Lung-201 Phase 2 study, which was sponsored by GSK. The study evaluated the belrestotug + dostarlimab combination in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC). Although the data showed improvements in the primary endpoint of objective response rate, the combination did not meet the study’s established criteria for a meaningful improvement in progression free survival compared to dostarlimab alone.
Based on these results, iTeos and GSK have mutually decided to terminate the development of belrestotug. The decision includes ending enrollment in the ongoing trial and discontinuing belrestotug-containing cohorts. iTeos has also started exploring strategic alternatives to maximize shareholder value while continuing to advance its efforts in immuno-oncology.
Read Announcement- Drug:
- Lung-201
- Announced Date:
- March 5, 2025
- Indication:
- In Patients (pts) With Previously Untreated Locally Advanced/Metastatic (LA/M) PD-L1 High (TPS >/=50%) Non-Small Cell Lung Cancer (NSCLC)
Announcement
iTeos Therapeutics provided a business update.
AI Summary
iTeos Therapeutics provided a business update highlighting several key milestones as they advance their immuno‐oncology pipeline. The company is preparing to report topline interim data from its GALAXIES Lung-201 trial in the second quarter of 2025. This dataset, which will include safety, overall response rate, and ctDNA data from more than 240 patients, is expected to shape the next steps for their lead program combining belrestotug and dostarlimab in collaboration with GSK.
Additionally, iTeos is accelerating the development of two promising Phase 1 therapeutic candidates. The EOS-984 plus pembrolizumab combination has enrolled a second dose cohort, while patient enrollment for the EOS-215 Phase 1 trial is anticipated to begin in 2Q25. With a robust cash balance of $655 million providing runway through 2027, the company is well-positioned to take bold steps forward in advancing its innovative science.
Read Announcement- Drug:
- Lung-201
- Announced Date:
- September 14, 2024
- Indication:
- In Patients (pts) With Previously Untreated Locally Advanced/Metastatic (LA/M) PD-L1 High (TPS >/=50%) Non-Small Cell Lung Cancer (NSCLC)
Announcement
iTeos Therapeutics 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).
AI Summary
iTeos Therapeutics announced encouraging follow-up interim data from the Phase 2 GALAXIES Lung-201 study, sponsored by its partner GSK. The study assessed the belrestotug + dostarlimab combination in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC). The trial showed a clinically meaningful objective response rate (ORR) of 63.3% to 76.7% with the combination, compared to a lower response rate with dostarlimab alone. Confirmed responses were around 60% across three doses with the belrestotug combination, marking a 30% difference versus monotherapy.
These results highlight the potential of the TIGIT:PD-1 doublet in improving tumor reduction and offering new treatment options for NSCLC patients. The promising findings support further investigation in the upcoming GALAXIES Lung-301 Phase 3 registration study.
Read Announcement- Drug:
- Lung-201
- Announced Date:
- August 20, 2024
- Indication:
- In Patients (pts) With Previously Untreated Locally Advanced/Metastatic (LA/M) PD-L1 High (TPS >/=50%) Non-Small Cell Lung Cancer (NSCLC)
Announcement
iTeos Therapeutics announced that 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, will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13-17, 2024 in Barcelona, Spain.
AI Summary
iTeos Therapeutics announced that interim data from the GALAXIES Lung-201 Phase 2 study will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. The study, sponsored by iTeos’ development partner GSK, evaluates a combination treatment using belrestotug and dostarlimab in patients with previously untreated, unresectable, advanced or metastatic PD-L1 high non-small cell lung cancer.
The interim analysis, titled “Interim Analysis of GALAXIES Lung-201,” will be shared on September 14, 2024, during a session focused on metastatic NSCLC. This presentation is significant as it may provide new insights into the effectiveness of this doublet therapy in activating the immune system against cancer, potentially offering an innovative treatment option for patients with this challenging form of lung cancer.
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Lung-301 - FDA Regulatory Timeline and Events
Lung-301 is a drug developed by iTeos Therapeutics for the following indication: Assessing Belrestotug and Dostarlimab in Previously Untreated, Unresectable Locally Advanced / Metastatic PD-L1 Selected Non-Small Cell Lung Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lung-301
- Announced Date:
- June 17, 2024
- Indication:
- Assessing Belrestotug and Dostarlimab in Previously Untreated, Unresectable Locally Advanced / Metastatic PD-L1 Selected Non-Small Cell Lung Cancer
Announcement
iTeos Therapeutics, Inc. announced that 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).
AI Summary
iTeos Therapeutics has launched its first global Phase 3 registration study to test a new cancer treatment combination. The trial compares the doublet of belrestotug and dostarlimab with placebo plus pembrolizumab in patients who have never been treated for, and who have, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC). The study will enroll around 1,000 participants across North America, South America, Europe, and Asia. It aims to assess key outcomes such as progression-free survival and overall survival. According to CEO Michel Detheux, Ph.D., this study is a major milestone in their efforts to develop a breakthrough, chemotherapy-free regimen for NSCLC patients, potentially setting new treatment benchmarks and paving the way for a broader therapeutic strategy in oncology.
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