U.S. FDA grants breakthrough therapy designation to Trodelvy for second-line treatment of extensive-stage small cell lung cancer
- The FDA has granted Breakthrough Therapy Designation to Trodelvy for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after platinum-based chemotherapy.
- This designation is based on promising results from the Phase 2 TROPiCS-03 study, which showed encouraging antitumor activity in both platinum-resistant and platinum-sensitive ES-SCLC.
- Gilead plans to initiate a Phase 3 clinical trial to further investigate Trodelvy in this patient population.
- Trodelvy is a Trop-2-directed antibody-drug conjugate, currently approved for certain breast cancer indications in over 50 countries.
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Immunocore begins phase 1/2 trial of IMC-R117C for advanced gastrointestinal cancers
- Immunocore has initiated a Phase 1/2 trial for IMC-R117C, targeting PIWIL1 in colorectal and other gastrointestinal cancers.
- The trial will evaluate IMC-R117C as a monotherapy and in combination with standard care in HLA-A*02:01-positive patients.
- IMC-R117C is the first immunotherapy targeting PIWIL1, a cancer-testis antigen overexpressed in several malignancies.
- The trial aims to assess safety, tolerability, pharmacokinetics, immunogenicity, and clinical activity of IMC-R117C.
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Affimed reports positive clinical update on AFM24/atezolizumab combination therapy in non-small cell lung cancer
- In NSCLC EGFR wild-type patients, the AFM24/atezolizumab combination showed an overall response rate (ORR) of 21% and a disease control rate (DCR) of 76%.
- In NSCLC EGFR mutant patients, the combination achieved an ORR of 24% and a DCR of 71%.
- A post-hoc analysis indicated that higher exposure to AFM24 is associated with better response rates and improved progression-free survival (PFS).
- Future development will use a 720 mg weekly dose of AFM24, which has shown a manageable safety profile in phase 1 studies.
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Actuate therapeutics announces positive interim phase 2 data of elraglusib in first line treatment of metastatic pancreatic cancer
- Interim Phase 2 data shows elraglusib with GnP significantly improves 1-year survival rate and median overall survival in metastatic pancreatic cancer.
- The trial met its primary endpoint with a 1-year survival rate of 43.6% in the elraglusib-GnP arm versus 22.5% in the control arm.
- A 37% reduction in risk of death was observed, with median overall survival of 9.3 months in the elraglusib-GnP arm compared to 7.2 months in the control arm.
- Topline data is anticipated in the first half of 2025, with plans to engage with the FDA for a proposed phase 3 registration trial.
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HighField Biopharmaceuticals receives IND clearance in China for HF50 trial
- HighField Biopharmaceuticals has received clearance from China's National Medical Products Administration to begin a clinical trial for HF50.
- HF50 is a TRAFsome T cell engager designed to treat advanced solid tumor cancers by converting T cells into cancer destroyers.
- The Phase 1 trial will assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy.
- The trial is expected to start in the first quarter of 2025.
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IDEAYA announces IDMC recommendation of move-forward dose in trial of darovasertib and crizotinib combination
- The Independent Data Monitoring Committee (IDMC) recommended a move-forward dose for Part 2a of the trial in 1L HLA-A2-negative metastatic uveal melanoma (MUM).
- The trial involves over 185 patients and aims for potential registration-enabling Phase 2/3 evaluation.
- The darovasertib and crizotinib combination has received FDA Fast Track designation for MUM.
- IDEAYA plans to initiate a Phase 3 registration-enabling study for neoadjuvant uveal melanoma in the first half of 2025.
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City of Hope scientists uncover protein that helps cancer cells dodge CAR T cell therapy
- City of Hope researchers identified a protein, YTHDF2, that helps cancer cells evade CAR T cell therapy.
- A new compound, CCI-38, was developed to target and suppress YTHDF2, potentially enhancing CAR T cell therapy effectiveness.
- YTHDF2 aids cancer cells by stabilizing energy production and reducing antigen biomarkers, making them harder to detect.
- Future research will focus on improving CCI-38's safety and effectiveness, with plans for clinical trials.
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Marker Therapeutics receives $9.5 million grant for MT-601 study in pancreatic cancer
- Marker Therapeutics awarded a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT).
- The grant supports the Phase 1 PANACEA study of MT-601 in metastatic pancreatic cancer.
- MT-601 is a multi-tumor associated antigen-specific T cell product targeting six tumor-specific antigens.
- The company plans to initiate the clinical program in 2025, leveraging additional funding from the NIH.
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Plus Therapeutics presents positive interim data for breast cancer patients with leptomeningeal metastases
- Phase 1 trial of Rhenium (186Re) Obisbemeda shows favorable responses in cerebrospinal fluid circulating tumor cell count, imaging, and clinical evaluation.
- Nine breast cancer patients with leptomeningeal metastases were treated, with a single intrathecal dose ranging from 6.6 to 66.14 mCi.
- Clinical benefit rates were high, with 100% for circulating tumor cells, 75% for MRI imaging, and 71% for clinical evaluation.
- Next steps include initiating a Phase 1b single-dose breast expansion cohort in Q1 2025 to further evaluate safety and efficacy.
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Sairopa achieves research milestones with Exelixis partnership
- Sairopa has reached a milestone in its partnership with Exelixis, receiving $35 million in clinical milestone payments in 2024.
- The collaboration focuses on ADU-1805, an anti-SIRPα antibody, with Exelixis holding an option for worldwide development and commercialization rights.
- ADU-1805 is currently in a phase 1 study, evaluating safety and pharmacokinetics in monotherapy and combination with a PD-1 inhibitor.
- The partnership aims to develop next-generation cancer therapies by combining Exelixis' oncology expertise with Sairopa's innovative immunotherapy research.
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Expert Systems celebrates milestone in clinical development of lonitoclax
- Expert Systems and Lomond Therapeutics report promising Phase 1 results for lonitoclax, a BCL-2 inhibitor.
- Lonitoclax shows advantages over venetoclax, with no significant safety signals and simpler administration.
- The drug demonstrated robust BCL-2 inhibition and minimal immunosuppressive activity in preclinical models.
- Next steps include further clinical development to potentially transform CLL and AML treatment.
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Johnson & Johnson seeks EMA approval for new ibrutinib indication in mantle cell lymphoma
- Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) for ibrutinib.
- The application seeks approval for use in adult patients with previously untreated mantle cell lymphoma (MCL) eligible for autologous stem cell transplant.
- The submission is supported by the Phase 3 TRIANGLE study, which showed improved efficacy with ibrutinib-based regimens.
- Next steps include awaiting EMA's decision on the application.
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ALX Oncology to present updated results from phase 2 ASPEN-06 clinical trial of evorpacept in patients with HER2-positive gastric cancer
- ALX Oncology will present updated results from the Phase 2 ASPEN-06 trial at the 2025 ASCO Gastrointestinal Cancers Symposium.
- The trial evaluates evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel against the combination alone for HER2-positive gastric cancer.
- ASPEN-06 is a randomized, multi-center, international trial involving patients who have previously received an anti-HER2 agent.
- The presentation will take place on January 23, 2025, and details will be available on ALX Oncology's website post-presentation.
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Coherus to present final phase 2 casdozokitug combination data in patients with metastatic hepatocellular carcinoma at ASCO-GI 2025
- Coherus BioSciences will present final data from a Phase 2 trial of casdozokitug combined with atezolizumab and bevacizumab for liver cancer at ASCO-GI 2025.
- The study involves treatment-naïve patients with unresectable or metastatic hepatocellular carcinoma (HCC).
- A new randomized Phase 2 study will evaluate casdozokitug with toripalimab and bevacizumab in first-line HCC, enrolling up to 72 patients.
- The HEPATORCH study showed promising results for toripalimab and bevacizumab, supporting further exploration of this combination in HCC.
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Verastem oncology provides a clinical update for RAMP 203 trial in advanced KRAS G12C mutant non-small cell lung cancer
- Verastem Oncology announced preliminary data for the triplet combination of avutometinib, sotorasib, and defactinib in the RAMP 203 Phase 1/2 study.
- No dose-limiting toxicities observed, with two out of three patients showing initial tumor reductions of at least 20%.
- The trial is progressing with additional enrollment expected, and an interim update planned for a medical meeting in the second half of 2025.
- RAMP 203 is a multicenter, open-label study evaluating the efficacy and safety of the combination in KRAS G12C mutant NSCLC patients.
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