Retevmo® (selpercatinib) Demonstrated Superior PFS vs a PD-1 Inhibitor + Chemo for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive NSCLC
“The LIBRETTO-431 trial aims to answer an important question about the selection of initial treatment for people with advanced RET fusion-positive NSCLC and these results suggest Retevmo should be considered a first-line standard of care,” said David Hyman, M.D., chief medical officer, Loxo@Lilly. “Additionally, this clinically meaningful achievement of improved outcomes underscores the importance of […]
U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation
“ABM-1310 is an orally administered medicine with high BRAF-mutation selectivity, high water solubility, and high blood-brain barrier permeability. It is one of innovative drugs independently developed by ABM. ABM-1310 is in Phase I studies at multiple clinical sites in the U.S. and China for BRAF V600-mutant advanced solid tumors. The interim result from its U.S. […]
FAILED TRIAL: Phase 3 AXLerate-OC Study of Batiraxcept in Platinum-Resistant Ovarian Cancer failed to meet primary endpoint of PFS improvement
“We are conducting additional analyses on the AXLerate-OC Phase 3 trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer,” said Gail McIntyre, Ph.D., DABT, Aravive’s President and Chief Executive Officer. “We want to thank the patients […]
FDA sends CRL for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with R/R Cutaneous T-Cell Lymphoma
“We appreciate the FDA’s expeditious review of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval. We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make […]
European Commission Approves LONSURF® (Trifluridine/tipiracil) in Combination With Bevacizumab in 3rd Line Refractory mCRC
“The approval by the European Commission is supported by data from the phase 3 SUNLIGHT trial for patients suffering from an advanced colorectal cancer who have already failed two prior chemotherapy regimens. The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway.”
Jemperli (dostarlimab) + chemo approved in the US as 1L treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “Today’s expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression. In the RUBY trial, Jemperli plus chemotherapy demonstrated […]
Immatics Announces $35 Million Equity Investment from Bristol Myers Squibb
“This investment is further testimony to the strength of the relationship and of our differentiated platform technologies that are the foundation of our TCR-based cell therapies and bispecifics,” commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “We remain steadfast in our commitment to advancing innovative treatment options for patients in their fight against cancer, […]
ImmunoGen Announces Multi-Target License and Option Agreement with ImmunoBiochem to Develop Next-Generation ADCs
“We are excited to partner with ImmunoBiochem, which brings a novel approach to tumor targeting for ADCs,” said Eric Westin, ImmunoGen’s Vice President of Clinical Development and Translational Sciences. “This agreement reflects our commitment to leverage our rich IP portfolio through strategic partnering in order to further reinvigorate our research and development in support of […]
Phase 3 Study of V940 (mRNA-4157) + KEYTRUDA initiated for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma
“As we continue our efforts to advance novel treatment options for patients with high-risk Stage IIB-IV melanoma, the initiation of the V940-001 Phase 3 trial represents an important step forward in these efforts and our study of individualized neoantigen therapy,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, […]
Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS To Discontinue
“The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead is deeply grateful to the patients, families, investigators, […]
Topline Data from UPLIFT Clinical Trial in Patients with Platinum-Resistant Ovarian Cancer and Strategic Reprioritization Announced
“We are deeply disappointed that UPLIFT’s efficacy failed to replicate previous data from approximately 100 patients in the dose expansion portion of our Phase 1b clinical trial,” said Dr. Arvin Yang, Senior Vice President and Chief Medical Officer of Mersana Therapeutics. “While the duration of response was longer than that from the dose expansion portion […]
UGN-102 Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials in NMIBC patients
“UGN-102 has demonstrated a robust and consistent therapeutic profile across multiple clinical trials, providing a compelling picture of its potential to be a transformational product and advance the standard of care away from repetitive surgery to a minimally invasive, non-surgical option for LG-IR-NMIBC,” says Liz Barrett, President and Chief Executive Officer of UroGen. “If approved, […]
FDA Grants Fast Track designation to IVS-3001 for the Treatment of Renal Cell Carcinoma
“We are thrilled to receive the FDA’s Fast Track designation for IVS-3001, said Dr. Jake Kushner, CEO of Invectys. “This recognition further validates the potential of our CAR-T cell therapy in revolutionizing cancer treatment for patients with solid tumors. The dedicated team at Invectys, as well as our partners, are committed to bringing this innovative […]
EMA Approves Clinical Trial Application (CTA) for AVC-201 for the Treatment of R/R AML and other CD123 Hematological Malignancies
“We are excited to build on the early success and promising activity and safety of our ongoing switchable autologous clinical program in AML (AVC-101) by now including what we believe is the most scientifically-compelling allogeneic technology in the industry,” said Andrew Schiermeier, AvenCell’s President & CEO. “With the application of both platform technologies, we are […]
European Commission Approves Trodelvy For Pre-Treated HR+/HER2- Metastatic Breast Cancer
“The European approval of sacituzumab govitecan is an important milestone for the European breast cancer community,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “We now have a new treatment option that has delivered a proven and clinically meaningful survival benefit for women in Europe with pre-treated […]
LEQEMBI approved by FDA for early Alzheimer’s disease treatment
The U.S. Food and Drug Administration (FDA) has now approved LEQEMBI under the traditional pathway making it the first approved treatment for early AD with a significant reduction in disease progression rate and slowing cognitive and functional decline. It marks Eisai’s success in research collaboration with Biogen and BioArctic for joint development and commercialization of […]
LianBio Partner NANOBIOTIX Enters into License Agreement with Janssen for NBTXR3, with LianBio Retaining Development and Commercialization Rights in Greater China, South Korea, Singapore and Thailand
“Data generated to date suggest NBTXR3 has potential to address the treatment limitations of standard of care radiotherapy across multiple solid tumor indications,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “We believe Nanobiotix’s collaboration with Janssen will provide additional expertise and financial resources to broadly develop NBTXR3 in areas of high unmet medical […]
First Patient Dosed with ELU001 in Expansion Cohort of Phase 1/2 Clinical Trial
“This is a notable milestone for the company, as we continue to progress our lead CDC candidate, ELU001, in this important Phase 1/2 trial. The safety data to date has been differentiating for ELU001 when compared to ADCs, including those targeting the same folate receptor alpha target, and we look forward to presenting ELU001 clinical […]
Ph 3 ENHANCE Study Of Magrolimab Plus Azacitidine In Higher-Risk MDS To Discontinue
“The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead is deeply grateful to the patients, families, investigators, […]
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 […]
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 […]
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 […]
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 […]
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 […]
FDA granted Fast Track Designation for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC)
“We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq,” said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. “This is another exciting achievement in our REQORSA development program, which further validates REQORSA’s potential […]
