European Commission approves lazertinib and amivantamab for EGFR-mutated NSCLC
- The European Commission has approved lazertinib in combination with amivantamab for first-line treatment of advanced NSCLC with specific EGFR mutations.
- Approval is based on the Phase 3 MARIPOSA study, which showed significant progression-free survival and overall survival benefits over osimertinib.
- The combination therapy demonstrated a median overall survival improvement expected to exceed one year.
- Next steps include presenting the landmark overall survival data at an upcoming medical meeting.
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Replimune's BLA for RP1 in advanced melanoma accepted for priority review
- The FDA has accepted Replimune's Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma.
- The application has been granted Priority Review with a PDUFA action date set for July 22, 2025.
- The BLA is supported by data from the IGNYTE trial, focusing on patients with anti-PD-1 failed melanoma.
- A confirmatory Phase 3 trial, IGNYTE-3, is ongoing globally to further assess RP1's efficacy.
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NiKang Therapeutics doses first patient in phase 1b/2 study of NKT2152 for hepatocellular carcinoma
- NiKang Therapeutics has initiated a phase 1b/2 clinical study of NKT2152 in combination with atezolizumab and bevacizumab for advanced hepatocellular carcinoma (HCC).
- The study is part of Roche's MORPHEUS-liver platform trial, focusing on first-line treatment for unresectable or advanced HCC.
- NKT2152 is a potent, selective HIF2α inhibitor with a favorable safety profile and significant anti-tumor efficacy in preclinical models.
- The trial aims to explore the potential of NKT2152 in combination therapies for solid tumors beyond clear cell renal cell carcinoma (ccRCC).
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Nanobiotix begins phase 2 study of JNJ-1900 for lung cancer
- Nanobiotix has dosed the first patient in the CONVERGE study, a Phase 2 trial for JNJ-1900 (NBTXR3) in Stage 3 unresectable non-small cell lung cancer.
- The study is sponsored by Janssen Pharmaceutica NV under a global license agreement.
- JNJ-1900 is a radioenhancer activated by radiotherapy, designed to induce tumor cell death and trigger an immune response.
- The trial aims to evaluate the efficacy of JNJ-1900 in combination with standard chemoradiation and consolidation durvalumab.
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Shuttle Pharma reaches milestone in patient enrollment for phase 2 clinical trial of ropidoxuridine for treatment of patients with glioblastoma
- Shuttle Pharma has achieved 25% enrollment in its Phase 2 clinical trial for ropidoxuridine, targeting glioblastoma.
- The trial involves 40 patients randomized into two dose levels to determine the optimal dose.
- Once the optimal dose is identified, 14 additional patients will be enrolled to reach statistical significance.
- The trial is conducted at multiple cancer centers, including Georgetown University Medical Center and Miami Cancer Institute.
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Antennova presents latest phase I/II data on ATN-022 in advanced/metastatic gastric cancer
- Antennova shared data from the Phase I/II CLINCH study on ATN-022 at ASCO GI 2025.
- The study involves patients with advanced/metastatic gastric cancer in China and Australia.
- In patients with CLDN 18.2 expression of IHC 2+ ≥ 20%, the ORR was 42.9% and DCR was 95.2%.
- ATN-022 showed a manageable safety profile and promising antitumor activity, supporting further investigations.
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Mainz Biomed initiates U.S. clinical study for next-gen colorectal cancer test
- Mainz Biomed launches eAArly DETECT 2, a U.S. feasibility study for its next-gen colorectal cancer test.
- The study will involve approximately 2,000 average-risk patients to validate previous results.
- Completion of enrollment is expected in the second half of 2025, with results by the fourth quarter.
- Based on outcomes, Mainz Biomed plans to initiate the ReconAAsense pivotal study in 2026.
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Xilio Therapeutics announces initial phase 2 data for vilastobart in combination with atezolizumab
- Initial phase 2 data shows a 27% response rate in heavily pre-treated MSS CRC patients without liver metastases.
- The combination therapy demonstrated a differentiated safety profile with low incidence of immune-related adverse events.
- Preliminary data indicates potential anti-tumor activity, with decreases in tumor biomarkers and improvement in clinical symptoms.
- Xilio plans to report updated data in mid-2025 and seeks opportunities for further development beyond the initial trial.
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Sonnet BioTherapeutics expands phase 1 SB101 trial to evaluate combination of SON-1010 with trabectedin in certain sarcomas
- Sonnet BioTherapeutics is expanding its Phase 1 SB101 trial to include a cohort evaluating SON-1010 with trabectedin in soft-tissue sarcoma patients.
- The trial aims to enhance progression-free survival by combining SON-1010's immune-oncology effects with trabectedin's therapeutic action.
- Enrollment for the new cohort is underway, with completion expected in H1 2025, and topline safety data anticipated in H2 2025.
- The expansion could lead to a larger Phase 2 study, potentially establishing the combination as a new treatment for soft-tissue sarcomas.
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Adagene to announce updated data from phase 1b/2 study of muzastotug in combination with Keytruda in colorectal cancer
- Adagene will present updated clinical data from its phase 1b/2 study of ADG126 in combination with Keytruda at the ASCO GI Cancers Symposium.
- The study focuses on microsatellite stable colorectal cancer (MSS CRC) and includes a dose escalation and expansion phase.
- New data will highlight results from a 20 mg/kg loading dose followed by a 10 mg/kg Q3W dose in combination with pembrolizumab.
- A virtual KOL event will be held to discuss the significance of CTLA-4 targeting in MSS CRC.
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MaaT Pharma receives positive DSMB review for phase 2b trial of MaaT033
- The DSMB completed its second safety assessment of the Phase 2b PHOEBUS trial and recommended continuation without modification.
- The trial is the largest randomized controlled trial assessing microbiome therapy in oncology, with 80 patients enrolled as of December 2024.
- MaaT033 is being tested as an adjunctive treatment for patients receiving Allo-HSCT, with a target enrollment of 387 patients across 56 sites.
- Upcoming milestones include DSMB reviews for ongoing safety and mortality imbalance, expected in Q1 and Q3 2025.
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Inhibrx biosciences announces preliminary data from phase 1 trial of ozekibart for colorectal cancer
- Inhibrx presented preliminary data from a Phase 1 trial of ozekibart (INBRX-109) combined with FOLFIRI for advanced colorectal cancer.
- Efficacy results showed 1 complete response, 3 partial responses, and 6 stable diseases among 10 patients evaluated.
- Treatment-emergent adverse events were reported in 84.6% of patients, mostly grade 1 or 2, with 30.8% experiencing grade ≥3 events.
- An expansion cohort is being initiated to validate findings, with data expected in Q3 2025.
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Cadonilimab phase III data for advanced gastric cancer published
- Cadonilimab, a PD-1/CTLA-4 bispecific antibody, shows significant survival benefits in advanced gastric cancer patients.
- Phase III study (COMPASSION-15) results published in Nature Medicine, highlighting improved overall survival.
- The regimen is approved for first-line treatment and is widely used in clinical practice.
- Further trials are underway, including a combination with VEGFR-2 monoclonal antibody for pretreated patients.
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BlossomHill Therapeutics doses first cohort in SOLARA trial for lung cancer
- BlossomHill Therapeutics has dosed the first cohort in the Phase 1/2 SOLARA trial for BH-30643.
- The trial targets EGFR- and HER2-mutated non-small cell lung cancer (NSCLC).
- BH-30643 is a macrocyclic, reversible, mutant-selective OMNI-EGFR inhibitor.
- The study includes dose escalation to identify recommended doses, followed by expansion to evaluate efficacy.
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Sarclisa approved in the EU for multiple myeloma treatment
- Sarclisa, an anti-CD38 therapy, approved in the EU for use with VRd in transplant-ineligible newly diagnosed multiple myeloma (NDMM).
- Approval based on IMROZ phase 3 study showing improved progression-free survival (PFS) with Sarclisa and VRd compared to VRd alone.
- This marks the third indication for Sarclisa in the EU, with previous approvals for relapsed/refractory multiple myeloma (R/R MM).
- Regulatory submissions for similar indications are under review in Japan and China.
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