Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
- The FDA has approved Rybrevant (amivantamab-vmjw) in combination with Lazcluze (lazertinib) as a first-line treatment for patients with EGFR-mutated advanced lung cancer.
- This approval provides a chemotherapy-free option for patients, potentially improving their quality of life.
- The decision was based on data from the MARIPOSA study, which demonstrated significant efficacy in this patient population.
- Next steps include monitoring real-world outcomes and potential further regulatory submissions in other regions.
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MOMA Therapeutics initiates Phase 1 trial for MOMA-313
- MOMA Therapeutics has dosed the first patient in its Phase 1 trial for MOMA-313, a novel polymerase theta helicase inhibitor.
- The trial will assess the safety and tolerability of MOMA-313, both as monotherapy and in combination with the PARP inhibitor olaparib.
- MOMA-313 targets solid tumors with DNA repair gene alterations, including prostate, pancreatic, and breast cancers.
- MOMA also announced the selection of MOMA-341, a Werner helicase inhibitor, as its second lead program, with an IND application expected in Q1 2025.
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ENHERTU type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer
- The European Medicines Agency (EMA) has validated the Type II Variation application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer.
- Validation confirms the application is complete and initiates the scientific review process by the EMA’s Committee for Medicinal Products for Human Use.
- The application is based on data from the DESTINY-Breast06 phase 3 trial, which evaluated ENHERTU versus investigator’s choice of chemotherapy in patients with HR positive, HER2 low or HER2 ultralow advanced or metastatic breast cancer.
- Additional regulatory submissions for ENHERTU in this indication are underway globally.
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European Medicines Agency validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
- The European Medicines Agency (EMA) has validated the application for Breyanzi (lisocabtagene maraleucel) for treating relapsed or refractory follicular lymphoma.
- Breyanzi is a CAR T cell therapy developed by Bristol Myers Squibb.
- Validation by the EMA is a critical step towards potential regulatory approval.
- Next steps include further review by the EMA, with potential approval contingent on clinical benefit verification.
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TEPKINLY (epcoritamab) receives second European Commission approval for the treatment of adults with relapsed/refractory follicular lymphoma
- TEPKINLY (epcoritamab) has received its second approval from the European Commission.
- The approval is for the treatment of adults with relapsed/refractory follicular lymphoma.
- This decision was based on clinical trial data demonstrating significant efficacy and safety.
- Next steps include potential regulatory actions in other geographies.
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Scorpion Therapeutics to present STX-478 initial phase 1/2 data at ESMO Congress 2024
- Scorpion Therapeutics will present initial clinical results from the Phase 1/2 study of STX-478 at ESMO Congress 2024.
- STX-478 is a mutant-selective PI3Kα inhibitor aimed at treating advanced solid tumors, particularly HR+/HER2- breast cancer.
- The presentation will cover safety, pharmacokinetic, pharmacodynamic data, and preliminary efficacy data.
- The late-breaking abstract will be published on the ESMO website on September 15, 2024.
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Adcendo and Multitude Therapeutics announce global development and commercialization agreement on first-in-class ADC drug candidate targeting tissue factor
- Adcendo obtains exclusive global development and commercialization rights for ADCE-T02, except in Greater China.
- Multitude to receive over $1 billion in upfront and milestone payments, plus tiered royalties on future sales.
- ADCE-T02 targets Tissue Factor, highly expressed in various cancers but limited in normal tissues.
- Clinical Trial Notification submitted in Australia; IND application in the US planned soon, with Phase I study expected in Q4 2024.
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Kineta reopens enrollment for the VISTA-101 clinical trial evaluating KVA12123 in patients with advanced solid tumor cancer
- Enrollment for the VISTA-101 Phase 1/2 clinical trial has resumed, effective immediately.
- The trial includes a monotherapy arm with KVA12123 and a combination arm with Merck’s KEYTRUDA (pembrolizumab).
- 30 patients have been enrolled to date, with full enrollment expected by the end of 2024.
- Initial results show partial response and stable disease in combination cohorts, and durable stable disease in monotherapy cohorts.
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PharmaTher’s Sairiyo Therapeutics receives approval to initiate a phase 1 human clinical trial of PD-001
- Sairiyo Therapeutics, owned by PharmaTher and PharmaDrug, received approval from the Australian Human Research Ethics Committee to start a Phase 1 clinical trial for PD-001.
- The trial will assess the bioavailability and pharmacokinetics of PD-001, a reformulated enteric-coated version of oral cepharanthine, in healthy volunteers.
- PD-001 has shown improved oral bioavailability in preclinical models, potentially enhancing its therapeutic efficacy for cancer and medical countermeasures.
- The study will support Sairiyo’s submission of an Investigational New Drug application to the U.S. FDA for subsequent Phase 2 and Phase 3 trials.
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Kineta Inc. reopens enrollment for VISTA-101 clinical trial evaluating KVA12123 in patients with advanced solid tumor cancer
- Kineta Inc. has reopened enrollment for the VISTA-101 Phase 1/2 clinical trial evaluating KVA12123.
- The trial includes a monotherapy arm with KVA12123 and a combination arm with Merck's KEYTRUDA® (pembrolizumab).
- 30 of the projected 39 patients have been enrolled, with full enrollment expected by the end of 2024.
- Initial results show partial response and stable disease in combination cohorts, and durable stable disease in monotherapy cohorts.
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