FDA approves first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU
“Roche is proud to lead the way in HER2 diagnostics through critical innovations that support the identification of patients who may benefit from novel HER2-targeted therapies,” said Thomas Schinecker, CEO of Roche Diagnostics. “Previously, metastatic breast cancer patients with a lower level of HER2 expression were considered to be part of the HER2-negative population and […]
FDA Approves Futibatinib For FGFR2+ Advanced Cholangiocarcinoma
“LYTGOBI is an effective, well-tolerated therapy for patients with intrahepatic CCA that can be taken orally,” said Tim Whitten, President and CEO of Taiho Oncology, Inc. “This approval is an important milestone for patients and may provide hope for improved outcomes. As someone whose family has been impacted by cholangiocarcinoma, I’m acutely aware of the […]
TILT Biotherapeutics Collaborates with MSD on Immunotherapy Clinical Trial in Checkpoint Inhibitor Refractory NSCLC
TILT Biotherapeutics’ CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients, said, “We already have clinical trials running in Europe and the USA in several cancer types, including ovarian cancer, head and neck cancer, and melanoma. We are planning several more, one of which is this new collaboration in NSCLC […]
Seagen & LAVA Therapeutics Announce Exclusive Worldwide License Agreement to Advance LAVA-1223, a Gamma Delta BiTE for EGFR-Expressing Solid Tumors
“Seagen is committed to driving innovation to improve the lives of people with cancer, and this agreement represents the company’s entry into a novel class of therapeutics that are designed to overcome the challenges of standard T cell engagers by leveraging the activity of a distinct T cell subset,” said Roger Dansey, M.D., interim CEO […]
New Long-Term Data from L-MIND Suggesting Durable Response to Treatment with Monjuvi® (tafasitamab-cxix) for Patients with R/R DLBCL
“The body of data presented at SOHO shows the long-term duration of response to tafasitamab in some patients with relapsed or refractory diffuse large B-cell lymphoma not eligible for autologous stem-cell transplant,” said Malte Peters, M.D., MorphoSys Chief Research and Development Officer. “These long-term follow-up results for L-MIND reaffirm our belief that tafasitamab plus lenalidomide […]
CAR T-Cell Therapy Targeting GPRC5D Antigen Proves Effective in First Trial in Patients with Resistant Multiple Myeloma
“CAR T-cell therapies targeting BCMA [the B cell maturation antigen] – a protein prevalent on immune system B cells – have shown promise in advanced myeloma, but many patients relapse,” says Eric L. Smith, MD, PhD, of Dana-Farber, the co-senior author of the study with Renier Brentjens, MD, PhD, of Roswell Park Comprehensive Cancer Center. […]
KEYTRUDA® Receives Four New Approvals in Japan, Including in High-Risk Early-Stage TNBC
“Based on compelling data from our clinical trial program, KEYTRUDA has become an important treatment option in Japan and now has 23 approved uses across 13 different types of cancer,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These four new approvals provide certain […]
FDA approved Lytgobi (futibatinib) for adults with advanced intrahepatic cholangiocarcinoma (iCCA) who have FGFR2 gene fusions or other rearrangements
“LYTGOBI is an effective, well-tolerated therapy for patients with intrahepatic CCA that can be taken orally,” said Tim Whitten, President and CEO of Taiho Oncology, Inc. “This approval is an important milestone for patients and may provide hope for improved outcomes. As someone whose family has been impacted by cholangiocarcinoma, I’m acutely aware of the […]
Clovis Oncology and Isotopia Announce Lutetium-177 Clinical Supply Agreement
“Clovis Oncology is committed to advancing FAP-2286’s clinical development program and emerging as a leader in targeted radionuclide therapy. A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement further secures our ability to achieve that goal,” said Patrick Mahaffy, President and CEO of Clovis Oncology. “In particular, we […]
Merck Enters Collaboration and Option to License Agreement with Nerviano Medical Sciences to Develop Next-Generation PARP1 Selective Inhibitor
“Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile,” said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare […]
Randomized Ph 2 trial of onvansertib + standard-of-care (SoC) FOLFIRI/bevacizumab in 2L RAS-mutated mCRC announced
“We designed our next clinical program in mCRC, a randomized Phase 2 trial we have named ONSEMBLE, to accelerate and de-risk our lead indication,” said Mark Erlander, PhD, chief executive officer of Cardiff Oncology. “Chief among ONSEMBLE’s objectives is to generate a randomized dataset to demonstrate the contribution of onvansertib over standard-of-care alone, validating the […]
Pivotal Ph 3 Trial of Olvi-Vec for the treatment of Platinum-Resistant/Refractory Ovarian Cancer initiated
“Initiating the OnPrime trial represents a major milestone for Genelux,” said Thomas D. Zindrick, President and CEO, Genelux. “Based on the positive results of our VIRO-15 Phase 2 trial, we believe that Olvi-Vec-primed immunochemotherapy has the potential to address the high unmet need of patients living with PRROC. Our goal in Phase 3 is to […]
Adjuvant Treatment with Opdivo Demonstrated Statistically Significant Improvement in RFS in Patients with Stage IIB/C Melanoma in the CheckMate-76K Trial
“Stage IIB/C melanoma patients are at high risk of disease recurrence, with approximately one third of stage IIB and half of stage IIC patients experiencing recurrence within five years after surgery. The results of the CheckMate -76K study represent a significant advancement for patients with stage IIB/C melanoma and an extension of our legacy in […]
Results from Ph 2 trial of zevorcabtagene autoleucel Ph 1b/2 study in RRMM patients announced
Dr. Raffaele Baffa, Chief Medical Officer of CARsgen Therapeutics, said: “Multiple myeloma is the second most common hematologic malignancy. People in the United States (US) living with or in remission from multiple myeloma is expected to increase to about 160 thousand in 2024. There remains a significant unmet medical need of multiple myeloma patients that […]
TUKYSA® (tucatinib) in Combination with Trastuzumab Granted Priority Review by FDA for Previously Treated HER2-Positive Metastatic Colorectal Cancer
“There are currently no FDA-approved therapies for metastatic colorectal cancer that specifically target HER2,” said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. “The FDA’s prioritization of our application for tucatinib in combination with trastuzumab supports our belief in its significant potential to benefit people with previously treated HER2-positive metastatic colorectal […]
Applications Submitted For Rubraca® Label Expansion In The US And European Union As First-Line Maintenance Treatment In Women With Advanced Ovarian Cancer
“We believe the compelling PFS results, the primary endpoint of the ATHENA-MONO trial, are strongly supportive of an approval and reinforce the potential of Rubraca as an important new first-line maintenance treatment for ovarian cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are grateful to the patients who participated in the […]
FDA Approves Retevmo® (selpercatinib) for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type
“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers, including pancreatic, colon and other cancers in need of new treatment options,” said Vivek Subbiah, M.D., associate professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and co-investigator […]
European Commission approves Opdualag (nivolumab + relatlimab) for the Treatment of Unresectable or Metastatic Melanoma with Tumor Cell PD-L1 Expression < 1%
“Opdualag is now the first approved LAG-3-blocking antibody combination for advanced melanoma in the European Union. The RELATIVITY-047 study demonstrated the important benefit of inhibiting both LAG-3 and PD-L1 with our novel immunotherapy combination,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “This is a continuation of […]
SpringWorks Announces Expansion of Global, Non-Exclusive Collaboration with GSK for Nirogacestat in Combination with Blenrep in Patients with Multiple Myeloma
“We are very pleased to expand our relationship with GSK to enable potential additional studies of Blenrep and nirogacestat,” said Saqib Islam, Chief Executive Officer of SpringWorks. “Our goal is to maximize the clinical impact of nirogacestat as a potentiator of BCMA targeted therapies and today’s announcement advances our opportunity to serve patients with multiple […]
KarMMa-9 Study of Abecma (idecabtagene vicleucel) in Newly Diagnosed Multiple
“Our focus at 2seventy is giving as much time as possible to patients who are battling cancer. We are moving rapidly to expand our clinical study program to determine utility of Abecma in newly diagnosed multiple myeloma patients with suboptimal response to transplant,” said Steve Bernstein, chief medical officer, 2seventy bio. “This population currently makes […]
Lumakras® (Sotorasib) + Vectibix® (Panitumumab) Shows Confirmed 30% ORR In Patients With KRAS G12C-Mutated mCRC
“We are thrilled to see these CodeBreaK 101 results, which show that LUMAKRAS plus Vectibix achieved a 30% confirmed objective response rate in patients with KRAS G12C-mutated metastatic colorectal cancer. Treatment response rates can be as low as 2% in this patient population, and the current standard of care offers a median progression-free survival benefit […]
Imfinzi + chemo further improved OS benefit in advanced biliary tract cancer in the TOPAZ-1 Ph 3 trial, reducing the risk of death by 24% in additional follow-up
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These longer-term data reinforce the survival benefit and well-tolerated safety profile of Imfinzi added to standard-of-care chemotherapy for patients with advanced biliary tract cancer. With these results, the exploratory data from the HIMALAYA trial and the recent FDA approval based on the TOPAZ-1 trial, we are […]
Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “For the first time, patients in the US with advanced biliary tract cancer have an immunotherapy-based treatment option that meaningfully extends survival and is well-tolerated. This approval for Imfinzi and chemotherapy advances our ambition to challenge treatment expectations and transform care for patients with gastrointestinal […]
BrainVectis receives clearance to conduct Phase I/II clinical trial for early-stage Huntington’s Disease
BrainVectis, an AskBio subsidiary, has received clearance to conduct the Phase I/II clinical trial for Huntington’s disease (HD) gene therapy BV-101 in France. BV-101, a novel adeno-associated virus gene therapy vector helps in the clearance of the mutant huntingtin protein in the diseased condition. BV-101 has been shown to provide neuroprotection and restore the function […]
AIM ImmunoTech and Roswell Park Commence Enrollment in Ph 2 Trial of Ampligen® (rintatolimod) in Primary PD-1/PD-L1 Resistant Melanoma
“The start of this NCI-funded clinical trial marks an important milestone for our Melanoma R&D program. Despite recent successes of immune checkpoint inhibitors in advanced-stage disease, only a minority of treated melanoma patients have a durable benefit, reinforcing the need to develop second-line therapies that are effective against checkpoint-refractory disease. Based on the data seen […]
Ph 3 CodeBreaK 200 trial of LUMAKRAS® (sotorasib) met its primary endpoint of PFS improvement over SoC chemotherapy in KRAS G12C-Mutated NSCLC
“Further analyses of the data are ongoing, and we look forward to sharing detailed data at an upcoming medical meeting,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are grateful to all of the investigators and patients who participated in this first randomized, controlled clinical trial of a […]
IND Application submitted to the FDA for Ph 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations
“At Immuneering we aim to create medicines for all patients with tumors driven by RAS mutations and other challenging MAPK pathway activation events. In our animal studies, IMM-1-104 strongly inhibited the growth of some of the most aggressive and deadly RAS mutant tumor models out there, without the need to combine with other agents and […]
Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced BTC
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “For the first time, patients in the US with advanced biliary tract cancer have an immunotherapy-based treatment option that meaningfully extends survival and is well-tolerated. This approval for Imfinzi and chemotherapy advances our ambition to challenge treatment expectations and transform care for patients with gastrointestinal […]
Oxford BioTherapeutics Announces Collaboration with Agenus toSupport the Clinical Development of OBT’s Antibody DrugConjugate OBT076 in combination with Agenus CPI Balstilimab
“I am very excited about our new partnership with Agenus, which will allow us to progress the clinical development of OBT076 in combination with balstilimab,” said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. “Our preliminary data suggest that depletion of CD205+ immuno-suppressive cells and subsequent T-cell activation after OBT076 treatment followed by […]
FDA Removes Partial Clinical Hold on NEON-2 Clinical Trial of Davoceticept (ALPN-202) in Combination with Pembrolizumab
FDA removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (ALPN-202), a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with pembrolizumab in adults with advanced malignancies.The FDA removed the hold after review of the Company’s Complete Response, which included a comprehensive review of the davoceticept safety database, as well […]
