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 […]
FAILED TRIAL: Ph 2 SELECT trial of vopratelimab + pimivalimab combination vs pimivalimab alone did not meet its primary endpoint of mean tumor change in in TISvopra Biomarker-Selected 2L NSCLC Patients
“The team did an outstanding job executing on a complex biomarker selected trial impacted by both the pandemic and the war in Ukraine. Although we are intrigued by the preliminary efficacy trends, particularly the landmark PFS and ORR in the lower vopra dose combination arm, the SELECT results do not support moving into registration studies […]
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 […]
FDA Approves Pemazyre® (Pemigatinib) For Myeloid/Lymphoid Neoplasms (MLNs) With FGFR1 Rearrangement
“The approval of Pemazyre represents an important treatment advancement for people living with MLNs with FGFR1 rearrangement who currently have limited treatment options,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte’s continued leadership and commitment to advancing care for patients with […]
Scemblix® approved by the European Commission for adult patients with CML
“Until now, patients with CML in Europe had oral TKI therapies with the same mechanism of action to turn to, and those experiencing significant side effects or resistance to these treatment options would often cycle between these very similar therapies, with little success in controlling their disease or improving their quality of life,” said Dr. […]
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 […]
SELLAS Reports Preliminary Data Showing Clinical Benefit from Phase 1/2 Clinical Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in Patients with WT1+ Advanced Ovarian Cancer
“These early data are an example of a new direction in development of immunotherapy for platinum-refractory ovarian cancer,” commented Jeffrey S. Weber, M.D., Ph.D.; Deputy Director of the Perlmutter Cancer Center at New York University (NYU)-Langone Health; Co-Director of its Melanoma Research Program Center; and Chair of SELLAS’ Scientific Advisory Board. “In patients who failed […]
Nurix Therapeutics Announces Positive Dose Finding Data in Chronic Lymphocytic Leukemia and Advances NX-2127 to Next Phase of Clinical Development
Our decision to advance NX-2127 in patients with CLL is based on the promising efficacy, safety, pharmacokinetic, and pharmacodynamic data from the ongoing Phase 1a dose escalation trial. There is a significant unmet need for a therapeutic approach with the potential to address the growing problem of relapse due to the development of BTK inhibitor […]
EMA Grants Orphan Drug Designation to Cornerstone Pharmaceuticals’ CPI-613® (Devimistat) for Treatment of Patients with Advanced Unresectable Biliary Tract Cancer
We are on a mission to develop cancer treatments for patients who have significant unmet clinical needs. Biliary tract cancer is considered rare and aggressive, with a large gap in effective treatment options,” said Sanjeev Luther, President and CEO of Cornerstone Pharmaceuticals. “Our goal is that this milestone will provide hope for patients and families […]
Elevation Oncology Announces FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene Fusions
There are currently no approved therapies that specifically target NRG1 fusions, and therefore, receipt of Fast Track designation in a tumor-agnostic setting is a significant step in addressing this unmet need,” said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. “NRG1 fusions are a type of genomic alteration that causes […]
European Commission Approves KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Adjuvant Monotherapy After Surgery for Locally Advanced or Early-Stage Triple-Negative Breast Cancer at High Risk of Recurrence
Triple-negative breast cancer has a high risk of recurrence within the first five years, so it’s meaningful for patients to have access to new therapies that can reduce the risk of disease progression,” said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. “The approval of this KEYTRUDA regimen […]
Repare Therapeutics Announces a Worldwide License and Collaboration Agreement with Roche for Camonsertib (RP-3500)
“Camonsertib has the potential to help cancer patients across numerous solid tumors as a monotherapy and possibly in combination with other agents,” said Kim Seth, Ph.D., EVP and Head of Business & Corporate Development at Repare. “Given the encouraging data Repare has generated for camonsertib as a potentially best-in-class ATR inhibitor with a promising tolerability […]
Bristol Myers Squibb to Acquire Turning Point Therapeutics, a Leading Precision Oncology Company
“The acquisition of Turning Point Therapeutics further broadens our leading oncology franchise by adding a best-in-class, late-stage precision oncology asset,” said Giovanni Caforio, M.D., Board Chair and Chief Executive Officer, Bristol Myers Squibb. “With this transaction, we are continuing our strong track record of strategic business development to further enhance our growth profile.”
Trethera Phase 1 Solid Tumors Trial Dose Escalates To Fourth Cohort After Safety Review Committee Determines Primary Trial Endpoint Achieved
Dr. Michael Shepard, Trethera Scientific Advisory Board member and Lasker laureate, commented, “These results hold importance in several ways. First, they allow us to continue the study safely to its conclusion, which indicates a positive trend toward safety and tolerability, the primary focus of this and any Phase 1a clinical trial. However, these unexpected observations […]
Merck Advances Development Programs in Oncology Focusing on Novel Mechanisms and Pathways
“While we did not see the outcomes we hoped for with this combination in this particularly challenging population of patients with platinum-resistant SCLC, we are confident in the potential of ATR inhibition, as combination with chemotherapy is only one avenue to take advantage of DNA Damage Response. We continue to progress our oral ATR inhibitor, […]
FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma
“Today brings welcome news for many advanced or metastatic esophageal squamous cell carcinoma patients and oncologists,” said Jaffer A. Ajani, M.D., CheckMate -648 co-first author and lead U.S. investigator, and professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “Unresectable advanced or metastatic esophageal squamous cell carcinoma is a challenging […]
