Positive Lead-In Data from Ongoing Ph 3 PEAK Trial of Bezuclastinib + Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST) announced
“These data reinforce our belief that the combination of bezuclastinib and sunitinib has the potential to become a new treatment option for second-line GIST patients,” said Andrew Robbins, President, and Chief Executive Officer at Cogent Biosciences. “We are pleased to demonstrate in a robust clinical dataset that the addition of bezuclastinib to sunitinib does not […]
Lynparza + Imfinzi reduced risk of disease progression or death by 37% vs. chemo + Avastin in ovarian cancer patients without tumour BRCA mutations in the DUO-O Ph 3 trial
Professor Philipp Harter, Director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany, and principal investigator for the trial, said: “The primary aim of first-line treatment of patients with advanced ovarian cancer is long-term control over the disease, but still too many patients progress quickly and face poor clinical outcomes today. Data from the […]
FDA Accepts for Priority Review Repotrectinib’s Application for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive NSCLC
“Patients with ROS1-positive non-small cell lung cancer face a rare disease with a significant unmet medical need given the limited durability of benefit and emergence of resistance to approved therapies,” said Jonathan Cheng, M.D., senior vice president and head of oncology development, Bristol Myers Squibb. “The FDA’s acceptance of this application marks an exciting milestone […]
Strategic Update provided on AFM24 Development Plan
“We believe that AFM24 can be an important addition to the treatment armamentarium for addressing EGFR mutant tumors as the early anti-tumor effects support further evaluation in a combination setting with the goal of achieving meaningful patient benefit. That is why we are adding an EGFR mutant NSCLC cohort to our ongoing phase 1/2 study […]
Lynparza + abiraterone approved in the US for the treatment of BRCA-mutated mCRPC
Andrew Armstrong, MD, ScM, of the Duke Cancer Institute, Durham, North Carolina, US, and an investigator in the trial, said: “Preventing or delaying radiographic progression or death is an important clinical endpoint in assessing cancer treatment and is very important to patients, their caregivers and their families. The PROpel results showed the Lynparza combination demonstrated […]
Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology Field
“Sony’s life science business has accumulated substantial knowledge in the field of cell analysis,” said Katsunori Ogawa, Head of Life Science & Technology Business Unit at Sony Corporation. “Through this collaboration, Sony is striving to contribute to the medical and drug discovery fields and provide further social value by leveraging Sony’s technological capabilities in the […]
IDEAYA Expands Clinical Trial Collaboration and Supply Agreements with Pfizer to Support Registrational Trial Evaluating Darovasertib and Crizotinib Combination in First-Line Metastatic Uveal Melanoma
“We are grateful to have Pfizer’s continued support – including their clinical expertise as a collaboration partner and with respect to drug supply, as we target initiation of our Phase 2/3 registrational trial in Q2 2023 for the darovasertib and crizotinib combination in first-line HLA-A2 negative MUM, with PFS as primary endpoint for potential accelerated […]
Enrollment completed in Immune Checkpoint Inhibitor Naïve Arm of VERSATILE-002 Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer
“Completing enrollment in the ICI naïve arm is an important milestone in the VERSATILE-002 Phase 2 trial and the ongoing development of PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent and/or metastatic HPV16-positive head and neck cancer,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “HPV-driven HNSCC is a […]
First Patient dosed in AIPAC-003 Phase II/III Trial for Metastatic Breast Cancer
Immutep CSO, Prof Frédéric Triebel said: “Commencing patient dosing for our AIPAC-003 trial of efti is a significant milestone for Immutep. Our aim is to improve clinical outcomes, focusing on a robust primary endpoint later in the phase III, overall survival, for patients with standard-of-care chemotherapy. Our previous trial, AIPAC, showed encouraging efficacy and safety […]
KEYTRUDA + LENVIMA Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as 1L Treatment for Patients With Advanced RCC
“KEYTRUDA plus LENVIMA continues to demonstrate durable clinical benefit as a first-line treatment for patients with advanced renal cell carcinoma, as shown by the clinically meaningful improvement in overall survival sustained with four years of follow up,” said Dr. Thomas Hutson, DO, Pharm.D., FACP, Director of the Urologic Oncology Program and Co-chair of the Urologic […]
IMFINZI + LYNPARZA and IMFINZI alone both significantly improved PFS in advanced endometrial cancer when added to chemotherapy
Shannon N. Westin, Professor of Gynecologic Oncology and Reproductive Medicine at the University of Texas MD Anderson Cancer Center, and principal investigator of the DUO-E trial, said: “These exciting data demonstrate durvalumab immunotherapy can significantly delay disease progression for patients with endometrial cancer and the addition of the PARP inhibitor olaparib can improve the benefit […]
FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic Cancer
“Orphan drug designation for rucosopasem highlights the urgent need for more treatment options to extend survival in patients with pancreatic cancer, which is the fourth leading cause of cancer death in the U.S.,” said Mel Sorensen, M.D., Galera’s President and CEO. “Following our announcement of encouraging survival results from our pilot proof-of-concept trial in patients […]
NDA for Fruquintinib for Treatment of Previously Treated mCRC Granted Priority Review; PDUFA: Nov 2023
“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. “There are significant needs for patients with this disease in the U.S., and we […]
EPKINLY (epcoritamab-bysp) Approved by FDA to Treat Adult Patients with R/R DLBCL
“DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient […]
VANFLYTA First FLT3 Inhibitor Approved in Japan for Patients with Newly Diagnosed FLT3-ITD Positive AML
“Patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia now will have the opportunity to receive targeted therapy with VANFLYTA,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “VANFLYTA is the only medicine developed and approved specifically for treatment of newly diagnosed FLT3-ITD positive AML in Japan and has […]
Gilead Strengthens Early Pipeline In Oncology And Inflammation Through The Acquisition Of XinThera
“Gilead and XinThera share similar missions to discover new therapies to treat cancer and inflammatory diseases, which drive our determination to unlock the body’s ability to better respond to these diseases,” said Chris LeMasters, who served as XinThera CEO. “We are eager to join Gilead and together explore the potential of our precision medicines as […]
Bayer and Bicycle Therapeutics Enter Strategic Collaboration for Development of Novel Targeted Radionuclide Therapies in Oncology
“At Bayer, we enter strategic collaborations to expand our access to innovation,” said Christian Rommel, Ph.D., Global Head of Research and Development and Member of the Executive Committee, Pharmaceuticals Division, Bayer. “With Bicycle’s proprietary peptide-based technology, we continue to strengthen our oncology development pipeline by adding next-generation targeted radiotherapeutics to address high unmet medical needs […]
First Patient Dosed in Ph I Trial Evaluating TG6050, a Novel IL-12-Armed Oncolytic Virus Administered Intravenously, in NSCLC
“We are pleased to initiate this first-in-human trial of TG6050 administered intravenously in patients with recurrent/metastatic advanced non-small cell lung cancer in great need for effective new therapeutic options,” said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. “Intravenous administration of TG6050 aims at significantly enhance the therapeutic potential of this promising oncolytic […]
New Results from Ph 2 Trial Confirm Benefit of Trilaciclib in Reducing Adverse Events Related to an ADC
“These preliminary results continue to show the consistent benefit of trilaciclib when administered prior to sacituzumab, relative to the previously published single agent safety profile of this ADC, including greater than 50 percent reductions in the incidence of events including neutropenia, anemia, and diarrhea,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “It […]
NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma
“We are glad to see the NMPA grants another Breakthrough Therapy Designation based on the preliminary results of IBI351 monotherapy in advanced colorectal carcinoma.” said Dr. Hui Zhou, Senior Vice President of Innovent. “The prognosis of advanced colorectal carcinoma patients with KRASG12C mutation is worse than KRAS wild type patients with limited therapeutic options. Currently, […]
European Commission approves Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma
“The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options. With today’s approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe. This further affirms our unparalleled scientific leadership in harnessing the IDH mutation and commitment to finding new […]
European Commission approves Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma
“The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options. With today’s approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe. This further affirms our unparalleled scientific leadership in harnessing the IDH mutation and commitment to finding new […]
Zai Lab Announces Strategic Partnership and Global License Agreement with MediLink Therapeutics for a Next Gen ADC Program in Oncology
“We are excited to collaborate with MediLink on this program. We will leverage our capabilities to advance the global development of YL212,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “This collaboration demonstrates our continued focus on developing cancer therapies including ADC drugs, further enriching our global […]
Eterna Therapeutics Acquires Allogeneic Immuno-Oncology Platform from Exacis Biotherapeutics
Gregory Fiore, M.D., President and CEO of Exacis, and member of Eterna’s Board of Directors, commented, “Exacis was started with the goals of improving patient outcomes and experiences as well as increasing access to life-saving treatments. Today’s announcement marks a key milestone on the path to achieving these goals. The Eterna Board and leadership are […]
First Patient Dosed in Ph 1/2 Clinical Trial of STX-478, Its Mutant-Selective PI3Kα Inhibitor for the Treatment of Breast Cancer and Other Solid Tumors
“We are excited to begin clinical evaluation of STX-478, our mutant-selective PI3Kα inhibitor with a potentially best-in-class profile, for the treatment of HR+/HER2- breast cancer and a wide array of other solid tumors,” said Axel Hoos, M.D., Ph.D, Chief Executive Officer of Scorpion. “The initiation of this clinical trial in just three years after our […]
ELAHERE® Demonstrates OS Benefit in the Ph 3 MIRASOL Trial in Patients with FRα-Positive Platinum-Resistant Ovarian Cancer
“I believe the data from the confirmatory MIRASOL trial are practice-changing. They demonstrate ELAHERE’s superiority to chemotherapy based on all efficacy endpoints, in particular overall survival, and build on the clinical benefit of ELAHERE previously reported in the SORAYA trial,” said Kathleen Moore, Associate Director of Clinical Research and Director of the Oklahoma TSET/Sarah Cannon […]
Updated Results from ORIENT-31 Study of Sintilimab + Chemo +/- Bevacizumab in Patients with EGFR-TKI failed EGFR-mutated nsqNSCLC announced
Dr. Hui Zhou, Senior Vice President of Innovent, stated, “the ORIENT-31 study is the first Phase 3 study that met primary endpoints in the world evaluating efficacy of PD-1 inhibitor and chemotherapy with or without bevacizumab in patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy. The results of first and second […]
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with R/R DLBCL
“New therapeutic options that are readily and broadly available are urgently needed for people with relapsing diffuse large B-cell lymphoma, which can become fatal without immediate treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The CHMP’s recommendation for Columvi brings us closer to providing a new, fixed-duration […]
POINT Biopharma Announce FDA Grants Fast Track Designation for 177Lu-PNT2002 for the Treatment of mCRPC
“Fast track designation by the FDA is an important milestone and recognizes the potential for 177Lu-PNT2002 to address the significant unmet need for mCRPC patients,” said Jean-Claude Provost, M.D., Chief Medical Officer at Lantheus. “We are encouraged by the FDA’s decision as it reflects the need for FDA approved and widely available treatments for these […]
EU approves Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
“With Breyanzi, people in Europe living with relapsed or refractory DLBCL now have a differentiated CAR T cell therapy option earlier in the treatment paradigm that provides long-term clinical benefit,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “This marks the approval of our third indication in Europe for […]
