ImCheck receives FDA fast track designation for ICT01 in combination with azacitidine and venetoclax in first-line acute myeloid leukemia
- ICT01, a humanized anti-butyrophilin 3A monoclonal antibody, has shown encouraging clinical data in AML.
- The FDA granted Fast Track designation for ICT01 in combination with azacitidine and venetoclax for AML patients unfit for induction chemotherapy.
- The designation is based on results from the Phase 1 dose-escalation portion of the EVICTION study.
- The EVICTION study is an open-label multicohort Phase 1/2a trial investigating ICT01 as monotherapy and combination therapy in solid and hematological tumors.
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FDA approves Merck’s Keytruda plus chemotherapy for advanced malignant pleural mesothelioma
- The FDA has approved Keytruda in combination with pemetrexed and platinum chemotherapy for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
- Approval is based on the IND.227/KEYNOTE-483 trial, which showed a 21% reduction in the risk of death and significant improvements in overall survival (OS) and progression-free survival (PFS).
- The trial enrolled 440 patients and demonstrated a median OS of 17.3 months for the Keytruda combination versus 16.1 months for chemotherapy alone.
- Keytruda plus chemotherapy also showed a higher overall response rate (ORR) of 52% compared to 29% for chemotherapy alone.
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Senhwa Biosciences submits IND to US FDA for pidnarulex pilot study in advanced solid tumors
- Senhwa Biosciences has submitted an IND application for Pidnarulex to the US FDA.
- The pilot study, sponsored by the NCI, will focus on pharmacodynamics in patients with advanced solid tumors.
- Future trials may explore Pidnarulex in combination with immunotherapy, ADCs, and PARP inhibitors.
- The study aims to investigate biomarker responses to Pidnarulex in patients with or without homologous recombination deficiency (HRD).
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Patritumab deruxtecan shows significant improvement in progression-free survival in phase 3 trial
- HERTHENA-Lung02 phase 3 trial met its primary endpoint of progression-free survival (PFS) in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
- Patritumab deruxtecan demonstrated statistically significant improvement versus platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy.
- Overall survival (OS) data were immature at the time of analysis; the trial will continue to assess OS as a secondary endpoint.
- The safety profile was consistent with previous trials, with no new safety signals identified. The majority of interstitial lung disease (ILD) events were low grade.
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Brenus Pharma raises $25 million to accelerate clinical trials of its precision cancer vaccines
- Brenus Pharma completed a $25 million Series A financing round led by Angelor, with participation from UI Investissement, Crédit Agricole, Noshaq, and Investsud.
- Funds will be used to fully fund the STC-1010 cancer vaccine’s first-in-human proof-of-concept trial for metastatic colorectal cancer patients.
- STC-1010 is based on the STC 'Stimulated-Tumor-(ghost)-Cells' technology platform, offering a new type of precision treatment.
- The phase I/IIA 'BreAK-CRC' study for STC-1010 is under review by European regulatory authorities and will evaluate safety, efficacy, and progression-free survival.
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Innovent delivers oral presentations on clinical data of IBI354 in advanced ovarian cancer, breast cancer and other solid tumors at the 2024 ESMO Congress
- Innovent presented clinical data of IBI354, a HER2 monoclonal antibody-camptothecin derivative conjugate, at the 2024 ESMO Congress.
- The Phase 1/2 study involved 368 participants with advanced solid tumors, including breast, ovarian, and colorectal cancers.
- IBI354 demonstrated a favorable safety profile with no dose-limiting toxicities and low incidence of severe treatment-related adverse events.
- Promising efficacy signals were observed, with high objective response rates and disease control rates in various tumor types, including platinum-resistant ovarian cancer and HER2-positive breast cancer.
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Biosyngen's CAR-T asset targeting solid tumors enters pivotal phase II trial
- Biosyngen's CAR-T therapy, BRG01, targeting Epstein-Barr virus (EBV) antigens for nasopharyngeal carcinoma (NPC), has entered a pivotal Phase II trial.
- Phase I trial data presented at ESMO 2024 showed 75% of patients experienced a sustained reduction in tumor burden, with several achieving complete response.
- BRG01 demonstrated no dose-limiting toxicity, neurotoxicity, or grade 2 or higher cytokine release syndrome, with the most common grade 3 adverse event being transient leukopenia.
- Regulatory approvals for Phase II trials were received in China (July) and the U.S. (August), with patient enrollment now underway.
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BostonGene and leading global cancer institutions announce Nature publication
- BostonGene and researchers from top cancer centers published a study in Nature Medicine.
- The study shows significant clinical responses and reduced inflammatory toxicity in relapsed/refractory T-cell lymphomas treated with duvelisib and romidepsin.
- A phase 1b/2a clinical trial investigated the safety and efficacy of duvelisib combined with romidepsin or bortezomib.
- BostonGene performed comprehensive molecular analyses to explore tumor features linked to therapeutic response.
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BeiGene receives Israeli Ministry of Health approval for Tevimbra for oesophageal squamous cell carcinoma
- The Israeli Ministry of Health has approved Tevimbra (tislelizumab) for adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC) after prior chemotherapy.
- Tevimbra is a humanized IgG4 anti-PD-1 monoclonal antibody designed to minimize binding to Fc-gamma receptors on macrophages.
- BeiGene plans to expand Tevimbra's availability in Israel and has submitted applications for other cancer indications, including non-small cell lung cancer (NSCLC) and gastric cancer (GC).
- Tevimbra has demonstrated potential survival benefits and quality of life improvements in multiple Phase 2 and Phase 3 trials, with over 900,000 patients prescribed globally.
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