OSE Immunotherapeutics launches global phase 3 study for cancer vaccine Tedopi in second-line NSCLC
- OSE Immunotherapeutics has initiated the global Phase 3 'Artemia' trial for Tedopi in second-line treatment of metastatic non-small cell lung cancer (NSCLC).
- The trial is being conducted in the US, Canada, Europe, and the UK, with regulatory authorizations from 14 countries.
- Artemia is an open-label, randomized trial comparing Tedopi monotherapy to standard care in HLA-A2 positive patients with secondary resistance to immune checkpoint inhibitors.
- The primary endpoint is overall survival, and the trial aims to enroll 363 patients to support regulatory registration in Europe and North America.
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Innovent delivers oral presentation of updated results from a pivotal phase 2 study of Dupert (fulzerasib) in patients with advanced non-small cell lung cancer harboring KRAS G12C mutation
- Innovent presented updated results from a pivotal Phase 2 clinical trial of Dupert (fulzerasib) at the 2024 World Conference on Lung Cancer.
- The study involved 116 NSCLC patients with KRAS G12C mutation, showing a confirmed objective response rate (ORR) of 49.1% and a disease control rate (DCR) of 90.5%.
- Median progression-free survival (PFS) was 9.7 months, with median overall survival (OS) not yet reached.
- Fulzerasib was well-tolerated, with treatment-related adverse events mostly being Grade 1-2.
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Oryzon announces first patient dosed in phase Ib study of iadademstat in first-line acute myeloid leukemia
- First patient dosed in an investigator-initiated Phase Ib trial of iadademstat in combination with venetoclax and azacitidine for newly diagnosed AML.
- Study aims to test the safety, tolerability, and best dose of the triple combination.
- Trial sponsored by Oregon Health & Science University (OHSU) Knight Cancer Institute.
- Iadademstat is also being evaluated in a company-sponsored Phase Ib trial in combination with gilteritinib for relapsed/refractory AML.
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Datopotamab deruxtecan shows median overall survival of 14.6 months in advanced nonsquamous non-small cell lung cancer
- TROPION-Lung01 phase 3 trial results show datopotamab deruxtecan (Dato-DXd) improves median overall survival (OS) to 14.6 months in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).
- Compared to docetaxel, Dato-DXd showed a 2.3-month improvement in OS for nonsquamous NSCLC patients (14.6 months vs. 12.3 months).
- The safety profile of Dato-DXd was consistent with previous analyses, showing lower rates of dose reduction and discontinuation due to adverse events compared to docetaxel.
- The OS data have been shared with health authorities currently reviewing applications for this indication.
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ImmunityBio presents positive long-term overall survival data in non-small cell lung cancer patients
- ImmunityBio announced positive results from its QUILT 3.055 trial, showing long-term survival of up to five years for advanced NSCLC patients treated with checkpoint inhibitors.
- The phase 2b study of ANKTIVA in combination with KEYTRUDA or OPDIVO showed long-term overall survival of 57% at 12 months and 34% at 18 months.
- The QUILT-3.055 study enrolled 86 patients with 2nd and 3rd line+ NSCLC who had failed prior CPI or CPI with chemotherapy.
- Based on these results, ImmunityBio is initiating Phase 3 trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd line NSCLC.
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Datopotamab deruxtecan shows promising results in advanced nonsquamous non-small cell lung cancer
- TROPION-Lung01 Phase III trial results show datopotamab deruxtecan (Dato-DXd) improved median overall survival (OS) to 14.6 months in patients with advanced nonsquamous NSCLC.
- Compared to docetaxel, Dato-DXd showed a 2.3-month improvement in OS (14.6 vs. 12.3 months) in nonsquamous NSCLC patients.
- The safety profile of Dato-DXd was consistent with previous analyses, showing lower rates of dose reduction and discontinuation due to adverse events compared to docetaxel.
- The OS data have been shared with health authorities currently reviewing applications for this indication.
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MAIA Biotechnology announces positive survival updates in Phase 2 study of THIO in non-small cell lung cancer
- MAIA Biotechnology reports favorable interim survival benefits from its Phase 2 trial, THIO-101, for advanced NSCLC.
- The trial evaluates THIO sequenced with Regeneron’s immune checkpoint inhibitor cemiplimab (Libtayo) in patients who failed two or more standard therapies.
- As of August 2024, 16 patients had survival follow-up surpassing 12 months, with a median survival follow-up in third-line treatment of 10.6 months.
- MAIA expects to release full efficacy results of THIO-101 this year.
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Replimune announces positive pre-BLA meeting with FDA and confirms BLA submission on track for 2H 2024
- Replimune completed a successful pre-BLA meeting with the FDA for RP1 in anti-PD1 failed melanoma.
- The company plans to submit a BLA for RP1 via the accelerated approval pathway in the second half of 2024.
- Topline results from the IGNYTE clinical trial showed a 33% overall response rate.
- Further data from the IGNYTE trial will be presented at the ESMO Annual Congress 2024.
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Onward Medical reports half year 2024 results and provides a business update
- Published Up-LIFT study results in Nature Medicine.
- Submitted De Novo application to FDA for ARC-EX System.
- Secured up to EUR 52.5M in growth financing from Runway Growth Capital.
- Achieved several milestones with ARC-BCI System, including FDA Breakthrough Device Designation.
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Vir Biotechnology closes exclusive worldwide license agreement with Sanofi
- Vir Biotechnology has closed an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs).
- The agreement includes the use of the PRO-XTEN masking platform for oncology and infectious disease applications.
- Key employees from Sanofi with expertise in TCEs and the PRO-XTEN platform will join Vir.
- Details on the TCEs and development plans will be shared at Vir’s R&D Day in November.
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