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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
