Long-Term Data from Omidubicel Ph 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers
“These data reinforce our commitment to advance transformational cell therapy research and underscore the potential of our NAM technology platform. Our lead stem cell therapy candidate, omidubicel, addresses the unmet need for patients with hematologic malignancies, demonstrated by the robust and growing body of encouraging clinical evidence, including the long-term follow up data and quality […]
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 […]
Puma Biotechnology Announces Exclusive License Agreement with Takeda for the Development and Commercialization of Alisertib
“There continues to be a need for new drugs for the treatment of metastatic ER- positive, HER2-negative breast cancer and triple negative breast cancer,” said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network […]
Elicio Therapeutics Receives $2.8 Million Grant from the Gastro-Intestinal Research Foundation (GIRF) to Fund Research for Two Therapeutic Cancer Vaccines
“We are excited to receive the grant from GIRF and look forward to broadening our pipeline by developing ELI-007 and ELI-008 to target these key cancer mutations. p53 hotspot mutants and mutant BRAF are examples of public cancer neoantigens shared across many patients and tumor types with limited therapeutic options for providing durable therapeutic benefit,” […]
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 […]
Enrollment of the Ph 1/2 OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer completed
“We are delighted to reach this important milestone of completing enrollment in our Phase I/II OVATION 2 Study with GEN-1 and are optimistic the study will show our technology’s ability to deliver the powerful immune-modulating agent IL-12,” said Corinne Le Goff, Ph.D., president and chief executive officer of Celsion Corporation. “Preliminary interim data in this […]
First Patient dosed in Ph 1b Expansion Study of PY159
“We developed PY159 to target TREM1 and reprogram myeloid cells within the tumor microenvironment to promote anti-tumor responses – a novel approach to TREM1 biology for anti-tumor drug development,” said Leonard Reyno, M.D., Pionyr Executive Vice President and Chief Medical Officer. “In the Phase 1a dose escalation study, PY159 was well tolerated in doses up […]
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 […]
Preliminary Ph 1 Trial Results For Zanidatamab Zovodotin (ZW49) announced
“We are grateful to the patients who participated in this trial and appreciate the collaborative efforts and dedication of the outstanding group of clinical investigators who are participating in this Phase 1 study,” said Neil Josephson, MD, Chief Medical Officer of Zymeworks. “These promising results provide significant momentum for the further clinical development of zanidatamab […]
Recommended Dose for Planned Registrational Study of NBTXR3 Plus Anti-PD-1 for Patients With mSCCHN Resistant to Prior Immunotherapy Established
The combined dose escalation and dose expansion parts of Study 1100 are expected to enroll up to 141 patients. The complete dose escalation part enrolled 29 patients in three cohorts: (i) head and neck lesions from LRR or R/M HNSCC eligible for anti-PD-1 therapy; (ii) lung mets from any primary cancer eligible for anti-PD-1 therapy; […]
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 […]
Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma
“There are currently no BTK inhibitors approved for MZL in Europe and with this positive opinion, we are one step closer to bringing forward a chemotherapy-free treatment option for this rare blood cancer. We look forward to a decision from the European Commission in the coming months,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, […]
Yescarta® First In Europe To Receive Positive CHMP Opinion For Use In 2L DLBCL And High-Grade B-Cell Lymphoma
“For people with DLBCL and HGBL who do not respond to first-line treatment or have an early relapse, outcomes are often poor and there are limited curative treatment options for these patients,” said Marie José Kersten, Professor of Hematology at Amsterdam University Medical Centers, Amsterdam. “If approved, axicabtagene ciloleucel may offer a new standard of […]
Oncologic Drugs Advisory Committee to review Zejula overall survival data from the NOVA Ph 3 trial in recurrent ovarian cancer
Hesham Abdullah, SVP, Global Head of Oncology Development, GSK said: “We believe PARP inhibitors, including Zejula, are important options for the maintenance treatment of patients with recurrent ovarian cancer, across all biomarker subgroups, who are in complete or partial response to platinum-based chemotherapy. We look forward to continuing our ongoing discussions with the FDA.”
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 […]
Lynparza approved in China as 1L maintenance treatment with bevacizumab for HRD+ve advanced ovarian cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “The maintenance treatment of Lynparza in combination with bevacizumab has shown to both improve progression-free survival and provide a clinically meaningful improvement in overall survival in patients with HRD-positive advanced ovarian cancer following response to platinum-based chemotherapy. I am thrilled we can now bring this […]
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 […]
Detailed Results from Ph 3 COSMIC-313 Pivotal Trial in Patients with 1L RCC announced
“We are pleased to share a more detailed picture of this triplet combination of cabozantinib, nivolumab and ipilimumab in patients with advanced kidney cancer at ESMO this year, reinforcing our longstanding commitment to this patient community,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “We […]
Dose-Escalation Results from Ph 1 STELLAR-001 Trial of XL092 +/- atezolizumab in Patients with Advanced Solid Tumors announced
“We are pleased to present these findings from the dose-escalation stage of STELLAR-001 at ESMO, which show XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels, with a manageable safety profile,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development […]
Trodelvy® Significantly Improved OS In Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients In TROPiCS-02 Study
“It is outstanding to see a clinically meaningful survival benefit of over three months for patients with pre-treated HR+/HER2- metastatic breast cancer,” said Hope S. Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, U.S. “Nearly all patients with HR+/HER2- metastatic […]
