KEYTRUDA + Trastuzumab + Chemo Met Primary Endpoint of PFS as 1L Treatment in Patients With HER2-Positive Advanced GEJ Adenocarcinoma
“These new data from KEYNOTE-811, demonstrating a significant improvement in progression-free survival, are meaningful and build on the earlier insights from this study that supported the accelerated approval of this KEYTRUDA combination in the U.S. for certain patients with HER2-positive gastric or GEJ adenocarcinoma,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research […]
2nd Positive Interim Clinical Trial Data Readout announced in R/R mCRC in Phase 1b/2a IMX-110 IMMINENT-01 Clinical Trial
“We are encouraged that in these early cohorts of patients receiving just a fraction of what we believe will be the optimal dose, we continue to see signals of activity of IMX-110 in relapsed/refractory metastatic colorectal cancer patients that received a median of 8 lines of anti-cancer therapies that failed to halt cancer growth prior […]
Ph 3 KEYNOTE-585 Trial in Locally Advanced Resectable GEJ Adenocarcinoma didn’t meet primary endpoint of EFS improvement
“While a statistically significant improvement in pathological complete response was observed in this study, we are disappointed that the KEYTRUDA regimen did not significantly improve event-free survival, a result that underscores the challenges in treating locally advanced resectable gastric cancer,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “Innovative research in […]
Ph 3 KEYNOTE-A18 Trial Met Primary Endpoint of PFS in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
“The role of KEYTRUDA is already established in certain patients with persistent, recurrent or metastatic cervical cancer, and these results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We are encouraged by these […]
Treatment with RYBREVANT® (amivantamab-vmjw) + Chemo Resulted in Statistically Significant and Clinically Meaningful Improvement in PFS in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive NSCLC
“The results from the PAPILLON study support the efficacy of RYBREVANT plus chemotherapy in the treatment of patients with non-small cell lung cancer with exon 20 insertion mutations,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “RYBREVANT was the first therapy approved in the relapsed/refractory setting for patients […]
FDA Grants Fast Track Designation to ARX517 for the Treatment of mCRPC
“Receiving Fast Track designation from the FDA reinforces Ambrx’s belief in ARX517 as a potential novel treatment for mCRPC and underscores the urgent need for improved treatment options for patients at this advanced stage of prostate cancer,” said Sandra Aung, Ph.D., Chief Clinical Officer of Ambrx.
Favorable IDMC Recommendation to Continue Ph 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer
“Completion of the interim analysis with the DMC’s recommendation to continue PANOVA-3 to completion marks another important step in pursuit of our mission to treat patients with difficult solid tumors of the abdomen,” said Asaf Danziger, Novocure’s Chief Executive Officer. “I would like to express my thanks to our patients and investigators. We look forward […]
FDA grants Fast Track Designation to Selinexor for the Treatment of Myelofibrosis
“Fast Track Designation for selinexor highlights its potential to address the unmet medical need in myelofibrosis, an important acknowledgement as we continue our pivotal Phase 3 study,” said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. “Selinexor’s unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis. We have […]
EMA provides negative Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced NSCLC with a KRAS G12C Mutation
“We remain steadfast in our belief in the potential of adagrasib to provide hope for patients in the European Union,” said David Meek, chief executive officer, Mirati Therapeutics, Inc. “We will continue to work closely with the EMA and the CHMP to bring adagrasib to eligible patients. We are committed to delivering therapeutic options for […]
FDA accepts Filing of NDA for Rivoceranib + Camrelizumab as a First-line Treatment for Unresectable HCC
“Rivoceranib plus camrelizumab has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer. “With the FDA’s acceptance of our new drug application, we are pleased to reach another milestone in the development of this combination therapy. We look forward to working closely with […]
Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with R/R DLBCL
“DLBCL is an aggressive and often treatment-resistant disease with limited therapeutic options for patients whose disease is refractory or who have experienced relapse after multiple lines of therapy,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “Subcutaneous epcoritamab could become a promising treatment […]
Positive EU CHMP Opinion for KEYTRUDA + Trastuzumab + Chemo as 1L Treatment for HER2-Positive Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1)
“This positive CHMP opinion reinforces our commitment to bringing meaningful treatment options to patients living with HER2-positive gastric or GEJ cancer, whose tumors express PD-L1 with a combined positive score ≥1, in the European Union,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We look forward to the European Commission’s decision […]
FDA Grants Orphan Drug Designation to ‘SNB-101’ for Small Cell Lung Cancer
US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101, a new polymer nanoparticle drug under development. SNB-101 is the world’s first nanoparticle anticancer drug that has developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea, and […]
Positive CHMP Opinions for TALVEY (talquetamab) and TECVAYLI (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
“With talquetamab, a novel bispecific antibody targeting GPRC5D, we look to build on our legacy of innovation and bring forward a vital new treatment option for patients with relapsed and refractory multiple myeloma, who have a poor prognosis,” said Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s recommendation […]
VANFLYTA First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML
“The approval of VANFLYTA represents a significant advancement for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which is one of the most aggressive and difficult-to-treat subtypes,” said Harry P. Erba, MD, PhD, Professor of Medicine, Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke Cancer Institute. “In the QuANTUM-First trial, […]
DRI Healthcare Trust Announces Acquisition of an Additional Royalty Interest in the Worldwide Sales of VONJO® (pacritinib)
“VONJO has addressed a significant unmet need in cytopenic MF patients and has seen an incredible uptake in its first year on the market,” said Behzad Khosrowshahi, Chief Executive Officer of the Trust. “We are excited to purchase a second royalty on this long duration, high-quality asset. This is the second royalty acquisition our team […]
NANOBIOTIX Announces License Agreement for Worldwide Co-development and Commercialization of Radioenhancer NBTXR3
“As pioneers in the field of nanotherapeutics for the past 20 years, we knew that the true impact of our innovation in oncology would be in its potential to reach millions of patients around the world. For that, we needed to find the right partner, at the right time, with proven global development and commercialization […]
Eisai Transfers All Future Economic Rights for Elacestrant, a Selective Estrogen Receptor Degrader, to DRI Healthcare
In this agreement with DRI Healthcare, Eisai transfers to DRI Healthcare all of its future economic rights. Eisai will receive an upfront payment of 85 million U.S. dollars for the transfer. As a result of this transaction, Eisai anticipates no changes to its consolidated financial forecast for the period ended March 31, 2024.
AbbVie terminated a 2020 collaboration with Jacobio Pharmaceuticals centred on the development and commercialisation of SHP2 inhibitors
The Company announced today that AbbVie has delivered the termination notice of the parties’ license and collaboration agreement (the “Agreement”) for the global development and commercialization of SHP2 inhibitors licensed by Jacobio to AbbVie under the Agreement, as part of AbbVie’s overall strategic decisions on its portfolio priorities. Following the termination of the Agreement, Jacobio […]
BeiGene and DualityBio Announce Partnership to Advance Differentiated Antibody Drug Conjugate (ADC) Therapy for Solid Tumors
“With one of the industry’s leading global oncology research teams, we are investing in highly impactful therapeutic modalities such as ADCs that complement our dynamic and growing pipeline in solid tumors,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “Through this strategic partnership with DualityBio, we are well positioned to advance this asset […]
KSQ Therapeutics Enters Worldwide License Agreement With Roche For KSQ-4279
“We believe KSQ-4279, which was discovered through our proprietary CRISPRomics® platform, has incredible potential to help patients with a variety of solid tumors based on the strong preclinical data we have seen to date. We are confident Roche is the right partner to further the development of KSQ-4279 and maximize its benefits for patients,” said […]
Initiation of Randomized Controlled Part B of the DeFianCe Study of DKN-01 in Colorectal Cancer Patients Announced
“Part A of the DeFianCe study enrolled an aggressive heterogenous population of second-line CRC patients representative of the second-line population that we see in the clinic who have poor outcomes on standard of care drugs and are in need of new therapies,” said Zev Wainberg, MD, Professor Medicine at UCLA and co-director of the UCLA […]
Enrollment in Phase 1/2 Study Discontinued; Development of THE-630 in Patients with GIST Terminated
“We are disappointed that we will not be able to achieve the target exposure for pan-variant inhibition with THE-630, as we continue to believe a therapy with potent activity against all major classes of activating and resistance mutations in KIT has the potential to confer significant clinical benefit, given the unmet need in GIST,” said […]
Enrollment Update Provided for Ongoing Phase 2 Karisma-Endoxifen Clinical Trial
“We are excited about the progress we’ve made in our mammographic breast density study and look forward to fully enrolling the trial later this year and seeing data in 2024,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “There are currently no approved treatments for women diagnosed with elevated breast density. We feel […]
Voluntary Pause of Enrollment in the Ph 2 LOTIS-9 Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients Announced
“Our top priority is the safety of every patient who participates in our clinical trials,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Given the aggregate of the respiratory-related events seen in the trial, we implemented a voluntary pause of enrollment to allow for a thorough investigation of the data set. This trial includes […]
First Patient Treated in Mainland China for the Global Phase 3 FORTITUDE-101 Study of Bemarituzumab in First-Line Gastric Cancer
“Approximately 30 percent of advanced HER2-negative gastric cancer patients are estimated to have FGFR2b overexpression, and currently, there are no approved treatments targeting FGFR2b in gastric cancer,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “We are focused on expanding treatment options to patients with advanced cancer, […]
Opdivo + Chemo Shows OS & PFS Benefit for Cisplatin-Eligible Patients with Unresectable or Metastatic Urothelial Carcinoma in the Phase 3 CheckMate -901 Trial
“Today’s news is yet another example of the power of immunotherapy combinations to transform outcomes for patients with cancer. Opdivo with cisplatin-based chemotherapy is the first immunotherapy-based combination to improve both overall survival and progression-free survivalin patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, reinforcing the benefits of […]
Positive data update provided on best response to therapy with first complete response in GLORIA trial in GBM, bringing 50% of patients in expansion arm to complete or near-complete response
“We are very pleased to report this highly positive update from the expansion arm of our GLORIA clinical trial evaluating our lead asset NOX-A12 in combination with radiotherapy and bevacizumab in glioblastoma,” said Aram Mangasarian, CEO of TME Pharma. “It is very encouraging to see one patient achieve no detectable tumor and two patients coming […]
Updates on DCR in the Part A safety lead-in of THIO-101 phase 2 trial of THIO + cemiplimab in patients with advanced NSCLC announced
“The 82% disease control rate observed so far with this combination is highly encouraging, especially in the heavily pre-treated population with previous immune CPI resistance, where typically the Disease Control Rates are in the 25-35% range. This preliminary data aligns with our pre-clinical data which showed that THIO, followed by an immune checkpoint inhibitor, greatly […]
Supportive interim data from Phase 2 head and neck cancer trial with setanaxib announced
“Based on the encouraging clinical and transcriptomic results, data clearly support the continuation of the trial, which will read out on tumor size and progression free survival in the full trial population next year. Also, it is interesting that the transcriptomic results clearly pointed to beneficial impact on 2 fibrosis‑related signaling pathways, supporting the presumed […]
