Evotec announces agreement with Janssen to develop immune-based therapies
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are very excited about this collaboration with Janssen. Novel immune-based therapies with disease-relevant, targeted mechanisms are expected to benefit large number of patients. Evotec is committed to leading the way in transformational innovation to treat and ultimately cure diseases of high unmet need.”
KEYNOTE-991 Trial Evaluating KEYTRUDA® Plus Enzalutamide and Androgen Deprivation Therapy in Patients With mHSPC to Stop for Futility
“There is a significant unmet need for patients with advanced prostate cancer, and the outcome of this study is an important reminder that this disease remains very difficult to treat,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation in this study, […]
Ongoing MGTA-117 Ph 1/2 Dose-Escalation Clinical Trial in R/R AML and MDS paused
First Patient dosed in Ph I/Ib Clinical Trial (COVALENT-102) of BMF-219 in KRAS Mutant Solid Tumors
“We are eager to explore the potential of BMF-219 as a pan-KRAS inhibitor in patients with three of the most prominent KRAS-mutant solid tumor types, including those with tumors that have failed to respond to investigational and approved mutation-specific KRAS inhibitors,” said Steve Morris, M.D., Biomea’s Chief Medical Officer. “As a covalent menin inhibitor, we […]
First Patient Dosed in VIRAGE, a Ph 2b Trial of Systemically Administered VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma
“The dosing of the first patient in our Phase 2b PDAC trial represents an important step in our pursuit to address unmet needs for patients with difficult-to-treat cancers,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “The incidence of PDAC continues to rise and while it continues to have one of the lowest […]
First Patient Dosed in ReSPECT-GBM Phase 2b Trial of Rhenium (186Re) Obisbemeda for Treatment of Recurrent Glioblastoma
“In the Phase 1/2a dose escalation trial, we showed that a rhenium (186Re) obisbemeda radiation dose of 22.3 mCi in an infused volume of 8.8 mL can be safely administered and that there is a statistically significant correlation between overall survival and both absorbed radiation dose to the tumor and percent tumor volume in the […]
TRANSCEND CLL 004 Trial of Breyanzi® (lisocabtagene maraleucel) Met Primary Endpoint of Complete Response Rate in R/R CLL Patients
“CLL is an incurable disease with complex biology and immune dysregulation that has made the development of T cell-based therapies that provide deep remission very challenging,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “In a population that has limited options, the TRANSCEND CLL 004 study represents the first […]
Ph 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) meets Primary Endpoint in Patients with Relapsed and Refractory Multiple Myeloma
“The CARTITUDE-4 study represents the first Phase 3 program in our comprehensive clinical development strategy for CARVYKTI, and further demonstrates our commitment to advance the treatment of patients with relapsed/refractory multiple myeloma,” said Jordan Schecter, M.D., Vice President, Clinical Development Cellular Therapy Program, Janssen Research & Development, LLC. “We look forward to the presentation of […]
ASCO GI: OS Data for Trifluridine/Tipiracil (LONSURF®) In Combination With Bevacizumab in Patients With Refractory mCRC presented
“The prognosis for metastatic colorectal cancer patients who do not respond to chemotherapy remains poor, with median survival times typically ranging from 4 to 8 months,” said Professor Josep Tabernero, MD, PhD, Head of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, and Principal Investigator for the SUNLIGHT trial. “Coupled with the fact that cases […]
Pivotal Data for Futibatinib in Previously Treated Patients With Metastatic Intrahepatic Cholangiocarcinoma published in the NEJM
“The FOENIX-CCA2 trial results demonstrate that futibatinib is an effective treatment for FGFR2 fusion/rearrangement positive cholangiocarcinoma. Its activity and safety profile offer a new treatment in this setting. These data reinforce the importance of molecular profiling in cholangiocarcinoma and represent a step forward for patients facing a difficult disease,” said Lipika Goyal, MD, MPhil, the […]
ASCO GI: Positive findings in 3L+ metastatic pancreatic cancer patients with doubled OS versus historical OS announced from trial QUILT 88
“We are encouraged by the positive results in these patients with 3rd, 4th, 5th and even 7th line advanced pancreatic cancer and the considered and helpful feedback from the FDA,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “Treatments for pancreatic cancer in the advanced setting remain an […]
ASCO GI: 84% Overall Survival at 18 Months from Ph 2 Trial Evaluating Zanidatamab in HER2-Expressing Metastatic Gastroesophageal Adenocarcinoma announced
“Gastroesophageal adenocarcinoma represents one of the most frequent tumor types worldwide and, tragically, a leading cause of cancer-related deaths. Compared to what has historically been reported for OS with the current approved standard of care1, the OS findings from the combination of zanidatamab and chemotherapy in this trial are very compelling,” said Dr. Elena Elimova, […]
Pivotal Ph 3 IMbrave050 trial of Tecentriq + Avastin in people with early-stage HCC at high risk of recurrence following surgery met primary endpoint of RFS
“Today, more than 70% of people with early-stage HCC may have their cancer return after surgery, which is associated with poorer prognosis and shorter survival. IMbrave050 is the first Phase III study to show that a cancer immunotherapy combination reduced the risk of disease returning in people with this type of HCC,” said Levi Garraway, […]
Results from ctDNA Analysis of INTRIGUE Ph 3 Clinical Study Presented
“We are pleased with the exploratory analysis, which showed that QINLOCK provided clinically meaningful benefit for second-line GIST patients based on the mutational drivers of their disease. QINLOCK’s impressive median progression free survival of 14.2 months compared to 1.5 months for sunitinib underscores the potential of QINLOCK to become the standard-of-care for second-line GIST patients […]
Data from Ph 1 UNIVERSAL Study of ALLO-715 for the Treatment of Relapsed/Refractory Multiple Myeloma published in Nature Medicine
“While new autologous CAR T therapies are a significant advance for patients with multiple myeloma, challenges inherent to those treatments remain, including manufacturing constraints and out-of-specification product, lengthy vein-to-vein time requiring bridging therapy or prolonged courses of treatment. These groundbreaking results demonstrate the potential for an off-the-shelf cell therapy to be delivered on demand to […]
Positive Data and Regulatory Update from Planned Interim Analysis of Ph 2 RAMP-201 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer Announced
“The interim data from the ongoing phase 2 RAMP 201 trial show that the combination of avutometinib with defactinib yields encouraging response rates with a well-tolerated safety profile in women with heavily pre-treated recurrent low-grade serous ovarian cancer,” said Dr. Susana Banerjee, MBBS, MA, PhD, FRCP, global lead investigator of the study, Consultant Medical Oncologist […]
KEYTRUDA® + Chemotherapy Significantly Improved OS Versus Chemotherapy in 1L Biliary Tract Cancer in KEYNOTE-966 Trial
“Biliary tract cancer is typically diagnosed at an advanced stage, and these patients face a poor prognosis, with five-year survival rates estimated to be approximately 5% to 15%,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are very encouraged by these overall survival […]
ASCO GI: Ph 3 NAPOLI 3 trial of Onivyde® regimen demonstrating positive survival results in 1L metastatic pancreatic ductal adenocarcinoma presented
“For the first time, a clinical study in the first-line setting for metastatic pancreatic ductal adenocarcinoma demonstrated superior overall survival and progression-free survival for an investigational regimen when compared to standard of care treatment with nab-paclitaxel and gemcitabine,” said Zev Wainberg, M.D. Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program. […]
ASCO GI: Final Results and New Xerna™ TME Panel Biomarker Data from Ph 2 Trial of Bavituximab + Pembrolizumab in 1L HCC Patients announced
David Hsieh, M.D., Assistant Professor at University of Texas Southwestern Medical Center and lead investigator of the Phase 2 trial, commented, “Our newly reported clinical data in front-line liver cancer show a near doubling of response rate in the subset of patients classified as biomarker-positive by the Xerna TME Panel. The high response rate seen […]
ASCO GI: Ph 2 Data of CTX-009 in Combination with Paclitaxel in Patients with Biliary Tract Cancers (BTC) Presented
“We are very pleased to see the maturing data from this study, particularly the median progression free survival of greater than 9 months and median overall survival of 12.5 months supporting the durable effect of CTX-009 in this patient population,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer and Scientific Founder of Compass. “Given that […]
Fast Track Designation from the FDA for Tamibarotene for the Treatment of Higher-Risk Myelodysplastic Syndrome
“Receipt of Fast Track designation for tamibarotene underscores both the potential of tamibarotene and the unmet need for HR-MDS patients, who have a poor prognosis due to the progressive nature of the disease,” said David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals. “No new therapies beyond hypomethylating agents have been approved since 2006, […]
IND cleared for SC291, a Hypoimmune-modified, CD19-targeted Allogeneic CAR T Therapy for Patients with B-Cell Malignancies
“The clearance of our SC291 IND is an important milestone, putting us closer to our goal of making an important medicine for patients with B-cell lymphomas and leukemias,” said Steve Harr, Sana’s President and CEO. “We look forward to understanding the safety, potency, and persistence of these cells in patients, and we are optimistic that […]
FDA clears IND for CLN-978 for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
“Despite advances for the treatment of B-cell malignancies, substantial unmet need remains for effective treatments. Preclinical evidence has demonstrated a differentiated profile for CLN-978 as it binds with very high affinity to CD19-expressing cells even at barely detectable levels of CD19.” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. “Consistent with our […]
FDA Clears IND Application for Ph 1/2a Clinical Trial of LB101, First LockBody® Candidate, for Solid Tumors
“We are very excited to be bringing our first LockBody candidate to the clinic and to be advancing a potentially transformative technology for patients with solid tumors,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “The clearance of our IND for LB101 is an important milestone for our company as we have an […]
Positive End of Phase II Meeting with the FDA for Bria-IMT(TM) Combination in Advanced Metastatic Breast Cancer announced
“The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with […]
FDA clears IND for Novel Bispecific CAR IMPT-314 to Treat Aggressive B-cell Lymphoma
“This IND clearance is a significant milestone for our company,” said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio. “Results from an investigator-led study evaluating this CAR T-cell therapy demonstrated that 70 percent of patients achieved a complete response with significant durability of remission. These initial efficacy results combined with the […]
FDA Accelerated Approval of TUKYSA® (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS WT, HER2-Positive mCRC
“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed following frontline therapy have had poor outcomes,” said John Strickler, M.D., associate professor of medicine, Duke University Medical Center, and lead investigator for the MOUNTAINEER trial. “The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients.”
FDA Approves KEYTRUDA® as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB, II, or IIIA NSCLC
“While there have been many advances for patients with metastatic disease, surgery remains the typical treatment for people with stage IB, II and IIIA non-small cell lung cancer. Unfortunately, many of these patients who undergo surgery still see their disease return,” said Roy S. Herbst, M.D., Ph.D., deputy director and chief of medical oncology, Yale […]
BRUKINSA® Approved in the U.S. for Chronic Lymphocytic Leukemia
Jennifer R. Brown, M.D., Ph.D., Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, commented “We have seen striking data from the BRUKINSA development program demonstrating significant and consistent efficacy across CLL patient sub-types, including the high-risk del17p/TP53 mutated population, and regardless of treatment setting. With extensive follow-up across […]
Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Historically, patients with breast cancer who have tumours with low levels of HER2 expression have been classified as HER2-negative, giving them limited treatment options beyond chemotherapy. This approval reinforces the important role Enhertu may have for patients with HER2-low disease and highlights the need to […]
