Alexis Peyroles, Chief Executive Officer of
- The primary endpoint, 1-year overall survival (OS) rate in the mITT** population, was achieved: a 46% 1-year overall survival (OS) rate for Tedopi® treated patients [95% CI: 33%, 59%] and more than the planned upper limit in the protocol (pre-specified futility boundary H0 <25% to reject; pre-specified alternative efficacy H1> 40% considered as clinically meaningful). This 46% OS rate was 10% higher than the standard of care (SoC) chemotherapy at 36% [95% CI: 21%, 54%].
- 1-year OS rate was confirmed at 47.5% in the modified per protocol*** population (those without major deviations) considered as the targeted population in this indication [95% CI: 34.3%, 60.9%] versus SoC at 34.4% [95% CI: 18.6% 53.2%].
- Median overall survival was longer in the ITT population at 9.8 months in the Tedopi® group versus 8.7 months in the SoC group, HR: 0.71 [95% CI: 0.44, 1.16]; p=0.17.
- Median overall survival difference was statistically significant in the targeted per protocol population with Tedopi® at 11.1 months versus 8.7 months for SoC, p=0.037; HR: 0.57 [95% CI: 0.34, 0.97].
- Other main secondary endpoints included similar disease control rate at 6 and 12 months between the two treatment groups.
- The time to ECOG deterioration was significantly longer in the Tedopi® group (8.4 vs 4.4 months; p=0.002). Survival after progression was also significantly longer in the Tedopi® group (7.5 vs 4.4 months; p=0.022).
- Good tolerance profile of Tedopi® with significantly less severe Treatment Emergent Adverse Effects (TEAS) (Tedopi® 14% vs SoC 43%, p<0.001).
Overall, benefit/risk ratio is favorable for Tedopi® and better than that of SoC in this post checkpoint inhibitors treated population.
Dr.
The study was conducted in HLA-A2 positive advanced NSCLC patients entering second- or third-line treatment after progression on immune checkpoint inhibitors (ICI), a patient population with very poor prognosis and currently no alternative treatment options.
* The ECOG score is a performance scale used to quantify the general health condition of a patient.
It is subdivided into 5 grades from 0 to 5, ranging from fully active (0) to fully disabled, then to death (5).
**mITT (multiple Intention-To-Treat) population: all randomized evaluable (≥12 months survival data) patients who received at least one dose of study treatment.
***Per protocol population: ITT population without protocol major deviations defined after a blind review by NSCLC experts.
ABOUT
- Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for Step-1 of the Phase 3 trial (
Atalante 1) in Non-Small CellLung Cancer post checkpoint inhibitor failure.
In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in monotherapy and in combination with checkpoint inhibitor Opdivo®. - BI 765063 (OSE-172, anti-SIRPα monoclonal antibody): developed in partnership with
Boehringer Ingelheim ; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors. - FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; Phase 2-ready asset in autoimmune diseases or in transplantation.
- OSE-127 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with
Servier ; positive Phase 1 results; two independent Phase 2 planned in ulcerative colitis (OSE sponsor) and in Sjögren’s syndrome (Servier sponsor) to start in Q4 2020. - BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.
- CoVepiT: a prophylactic vaccine against COVID-19, developed using SARS-CoV-2 optimized neoepitopes. Positive preclinical and human ex vivo results in
August 2020 , clinical trial expected to start end of 2020/early 2021.
Due to the COVID-19 crisis, accrual of new patients in the clinical trial TEDOPaM is temporarily suspended and initiation timelines for both Phase 2 trials of OSE-127 could be impacted during the coming months.
For more information: https://ose-immuno.com/en/
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Contacts
Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 | darren@lifescicomms.com +1 646 627 8387 |
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