IMUNON reports improved survival data from phase 2 OVATION 2 study
- IMUNON's Phase 2 OVATION 2 study shows increased median overall survival from 11 to 13 months for IMNN-001 treatment group.
- The study involved 112 patients with advanced ovarian cancer, comparing IMNN-001 plus chemotherapy to standard chemotherapy alone.
- No serious immune-related adverse events reported, maintaining a favorable safety profile for IMNN-001.
- IMUNON plans to initiate a Phase 3 pivotal trial for IMNN-001 in Q1 2025.
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Carvykti shows higher MRD negativity in CARTITUDE-4 study
- CARTITUDE-4 Phase 3 study shows Carvykti significantly increases MRD negativity rates in RRMM patients.
- 89% of patients treated with Carvykti achieved MRD negativity, compared to 38% with standard therapies.
- Carvykti demonstrated five-fold higher sustained MRD-negative complete response rates than standard therapies.
- The study highlights Carvykti's potential for deeper, sustained responses in multiple myeloma treatment.
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Carvykti shows significant improvement in MRD negativity for multiple myeloma
- CARVYKTI achieved 89% MRD negativity in the CARTITUDE-4 study, compared to 38% with standard therapies.
- The study involved 208 patients receiving CARVYKTI and 211 receiving standard therapies, with a median follow-up of 34 months.
- CARVYKTI is the first cell therapy to significantly extend overall survival in multiple myeloma.
- The data supported FDA and European Commission approvals for CARVYKTI in relapsed or refractory multiple myeloma.
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Immutep initiates TACTI-004 phase III trial in first line non-small cell lung cancer
- Immutep has started the TACTI-004 Phase III trial for first-line metastatic non-small cell lung cancer (1L NSCLC).
- The trial received approval from the Australian Therapeutic Goods Administration and is expected to enroll the first patient in Q1 2025.
- The study will evaluate eftilagimod alfa with KEYTRUDA and chemotherapy against KEYTRUDA with chemotherapy and placebo in ~750 patients.
- The trial will be conducted across over 150 sites in more than 25 countries, with dual primary endpoints of progression-free survival and overall survival.
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Pilatus Biosciences secures FDA orphan drug designation for PLT012
- Pilatus Biosciences received FDA Orphan Drug Designation for PLT012, targeting liver and intrahepatic bile duct cancer.
- PLT012 is a humanized anti-CD36 antibody with a dual mechanism of action, enhancing anti-tumor immunity.
- The designation provides development incentives, including tax credits and 7 years of marketing exclusivity upon approval.
- Pilatus plans to submit its first U.S. IND and begin patient dosing in 2025.
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Immune-Onc Therapeutics presents updated data from Phase 1b study of IO-202 in CMML patients
- Immune-Onc Therapeutics shared updated data from its Phase 1b study of IO-202, an anti-LILRB4 antibody, combined with azacitidine in CMML patients.
- The study showed a complete remission rate of 50% and an overall response rate of 66.7% among 18 efficacy evaluable patients.
- Patients with high LILRB4 expression achieved a complete remission rate of 83.3% and an overall response rate of 100%.
- The promising results support a pivotal study to evaluate IO-202 as a frontline treatment for hypomethylating agent-naïve CMML.
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Enterome’s immunotherapy EO2463 shows early clinical response in newly diagnosed follicular lymphoma
- EO2463 demonstrated a 46% objective response rate in early-stage follicular lymphoma, with 15% complete and 31% partial responses.
- The Phase 1/2 SIDNEY trial evaluates EO2463 as an alternative to 'watchful waiting' in asymptomatic patients.
- Treatment was well-tolerated with no severe adverse events, suggesting a safe option for early-stage disease.
- Biomarker analysis indicates early CD8+ T cell expansion may predict positive clinical outcomes.
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City of Hope reports promising results for novel immunotherapy in CLL trial
- City of Hope shared early results from a phase 1b/2 trial of epcoritamab for relapsed or refractory CLL.
- The trial involved 40 patients, with a 61% response rate in the monotherapy expansion cohort.
- Epcoritamab is a bispecific T cell engager targeting CD20 on B cells and CD3 on T cells.
- The study aims to enroll 184 participants, with ongoing monitoring of side effects and effectiveness.
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ALX Oncology presents promising data for evorpacept and zanidatamab in advanced breast cancer
- Phase 1b/2 trial shows promising anti-tumor activity in heavily pretreated HER2-positive breast cancer patients.
- Combination therapy of evorpacept and zanidatamab was well tolerated with a manageable safety profile.
- Cohort 1 (HER2-positive) showed a confirmed objective response rate (cORR) of 55.6% and median progression-free survival (mPFS) of 7.4 months.
- No treatment-related deaths or non-infectious pulmonary toxicities were observed.
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Cardiff Oncology announces positive initial data from first-line RAS-mutated mCRC clinical trial
- Initial results from the Phase 2 CRDF-004 trial show a 64% ORR in the 30mg onvansertib dose arm versus 33% in the control arm.
- The 30mg dose of onvansertib demonstrated deeper tumor regression compared to the 20mg dose.
- Onvansertib was well tolerated at both 20mg and 30mg doses.
- Additional clinical data from the CRDF-004 trial is expected in the first half of 2025.
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New and updated data for Genentech’s fixed-duration Columvi and Lunsumio at ASH 2024
- Genentech presented new data at ASH 2024 on Columvi and Lunsumio, showcasing their potential in treating aggressive and indolent lymphomas.
- The Phase II NP30179 study of Columvi showed a 40% complete response rate in relapsed or refractory large B-cell lymphoma, with a median duration of 29.8 months.
- Lunsumio's Phase II GO29781 study demonstrated long-lasting remissions in follicular lymphoma, with a 64% complete response rate at 45 months.
- Subcutaneous administration of Lunsumio showed pharmacokinetic non-inferiority to intravenous administration, with high response rates and manageable safety.
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BeiGene advances leadership in CLL at ASH 2024 with new data from its hematology franchise
- BeiGene presented new clinical data at the ASH 2024, highlighting BRUKINSA's role in treating CLL/SLL.
- The combination of BRUKINSA and sonrotoclax showed a 99% overall response rate in CLL patients.
- Phase 3 SEQUOIA study results confirmed BRUKINSA's efficacy, reducing progression risk by 71% compared to bendamustine-rituximab.
- BeiGene is developing BGB-16673, a BTK degrader, showing promising results in high-risk CLL patients.
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Sellas life sciences initiates interim analysis in phase 3 REGAL trial for AML
- The Phase 3 REGAL trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) has reached a pre-specified threshold of 60 events (deaths), triggering an interim analysis.
- The Independent Data Monitoring Committee (IDMC) will conduct the interim analysis in January 2025 to assess efficacy, futility, and safety.
- REGAL is an open-label trial focusing on AML patients in complete remission after second-line salvage therapy, with overall survival as the primary endpoint.
- Next steps include the IDMC's review and recommendations, which will be shared once available.
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Adding tafasitamab cuts risk of disease progression in follicular lymphoma
- The inMIND Phase III trial showed a 57% improvement in progression-free survival (PFS) for patients treated with tafasitamab, lenalidomide, and rituximab compared to a placebo group.
- 548 patients with relapsed or refractory follicular lymphoma participated, with a median follow-up of 14.1 months.
- Patients receiving tafasitamab had a median PFS of 22.4 months versus 13.9 months for the placebo group.
- The study will continue to follow patients for five years to assess overall survival.
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New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024
- Long-term data show Columvi and Lunsumio achieve durable remissions, reducing treatment-related travel burden due to less frequent dosing.
- Subcutaneous administration of Lunsumio shows non-inferiority to intravenous treatment, offering a potential outpatient option with shorter administration time.
- Phase II study of Lunsumio with Polivy shows improved efficacy and manageable safety compared to Rituximab with Polivy in relapsed/refractory large B-cell lymphoma.
- Ongoing studies aim to explore further treatment combinations and administration options to meet diverse patient needs.
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