Camizestrant significantly improved PFS vs. Faslodex in SERENA-2 Ph 2 trial in advanced ER-positive breast cancer
Mafalda Oliveira, MD, PhD, Vall d‘Hebron Institute of Oncology in Barcelona, Spain and lead investigator in the SERENA-2 Phase II trial, said: “The results from SERENA-2 show that camizestrant provides a significant improvement in progression-free survival compared to fulvestrant, which has been used to treat patients with HR-positive breast cancer for almost twenty years. These […]
Capivasertib plus Faslodex significantly improved PFS vs. Faslodex in CAPItello-291 Ph 3 trial
Nicholas Turner, MD, PhD, Professor of Molecular Oncology at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, London, UK, and principal investigator in the CAPItello-291 Phase III trial, said: “The CAPItello-291 Phase III trial results show capivasertib offers a clinically meaningful improvement in progression free survival for patients with HR-positive […]
Zentalis Pharmaceuticals Announces First ZN-c3 Clinical Development Collaboration with Pfizer
“We are extremely excited to announce this investigational study, which we believe will benefit greatly from the expertise and support gained through our collaboration with Pfizer,” said Carrie Brownstein, M.D., Chief Medical Officer of Zentalis. “Combining ZN-c3 with the BEACON agents in this study represents an opportunity in our ZN-c3 clinical development program, alongside ongoing […]
Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML
“There is a need for new targeted therapy options for patients with acute myeloid leukemia and the results of the QuANTUM-First trial showed that quizartinib in combination with standard chemotherapy has potential to change the current standard of care for newly diagnosed patients with the historically difficult to-treat FLT3-ITD subtype,” said Ken Takeshita, MD, Global […]
U.S. FDA Approves TECVAYLI (teclistamab-cqyv) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
“Today’s achievement, which marks an important addition to our diverse and growing oncology portfolio, strengthens our resolve to discover and develop much-needed cancer treatments for patients and physicians,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “The approval of TECVAYLI, which demonstrated an overall response rate of more […]
Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer based on Ph 3 HIMALAYA trial
Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator in the HIMALAYA Phase III trial, said: “Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favourable three-year survival rate in the HIMALAYA trial, […]
HOOKIPA Announces Strategic Collaboration And License Agreement With Roche To Develop Novel Arenaviral Immunotherapy For KRAS-Mutated Cancers
“Roche is an ideal partner, both in terms of development and reaching patients with novel cancer therapeutics. We look forward to working with them to benefit people with KRAS-mutated cancers,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “This collaboration validates the potential of our arenavirus platform and accelerates the development pathway to bring new […]
Erasca Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Evaluate ERAS-007 and Palbociclib Combination
“We are excited to expand our existing relationship with Pfizer to explore ERAS-007 in combination with palbociclib in RAS-mutated GI malignancies as part of our HERKULES-3 program,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Preclinical evidence supports synergistic anti-tumor effects when downstream RAS/MAPK pathway inhibition is combined with cell cycle inhibition in […]
First Patient Enrolled in DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients
“We believe that DKN-01 has broad clinical potential. Based on the role of DKK1 in suppressing the immune system in the tumor microenvironment and enabling resistance to chemotherapy in CRC, we are excited to explore this new indication, one of the most frequent and dangerous types of GI cancers where patients continue to look for […]
Ph I part of the clinical trial of Bria-IMT™, in combination with retifanlimab, in advanced breast cancer completed
“We are very impressed by the clinical data showing a favorable safety profile for our treatment in advanced breast cancer patients who have failed other therapies,” commented Dr. Del Priore, BriaCell’s Chief Medical Officer. “We look forward to further advancing this program and sharing the data in the coming months.”
Data from CheckMate -76K Shows that Opdivo Reduced the Risk of Recurrence or Death by 58% vs. Placebo in Patients with Completely Resected Stage IIB/C Melanoma
“Within five years after surgery, one third of stage IIB and one half of IIC patients see their cancer return. Helping reduce that risk remains a need to be addressed when it comes to treating melanoma,” said Professor Georgina Long, AO, MD, PhD, Co-Medical Director of Melanoma Institute Australia (MIA) and chair of melanoma medical […]
LuMIERE Ph 1 Data Of FAP-2286 announced
“The LuMIERE trial is the first prospective trial of a FAP peptide targeted radionuclide therapy and is currently in the dose escalation phase. To date we have not seen evidence of significant associated toxicities that would limit therapy, and have seen some evidence of early efficacy,” said Thomas A. Hope, M.D., Director of Molecular Therapy […]
FDA Grants Fast Track Designation to TTI-101 for Hepatocellular Carcinoma
“We are pleased to receive Fast Track designation for TTI-101 in HCC from the FDA,” said Imran Alibhai, PhD, CEO of Tvardi. “This designation provides validation of the compelling safety and efficacy we have seen in last-line HCC patients in our Phase 1 trial. This comes at a perfect time as we look forward to […]
NDA of BCMA CAR T Zevor-cel (CT053) accepted by China NMPA
Prof. Wenming Chen, the principal investigator of the CT053-MM-01 study, Director of Hematology Department, Beijing Chao-Yang Hospital, Capital Medical University, said: “Results from the LUMMICAR-1 study show that the fully human autologous BCMA CAR T-cell product, zevor-cel, demonstrated strong and durable efficacy in patients with relapsed/refractory multiple myeloma, and was generally well tolerated. We are […]
Yescarta Receives European Marketing Authorization For Use In 2L DLBCL And High-Grade B-Cell Lymphoma
“We are very proud to announce Kite’s fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world,” said Christi Shaw, CEO, Kite. “Today’s approval marks an important step by providing patients in Europe this option of CAR […]
Mirati Therapeutics & Aadi Bioscience Partner to Evaluate Adagrasib + Nab-sirolimus in Advanced NSCLC and Other Solid Tumors patients with a KRAS[G12C] Mutation
“We are pleased to collaborate with Aadi on this clinical study of adagrasib and nab-sirolimus. Our collaborative preclinical work has demonstrated that combinatorial mTOR and KRAS inhibition addresses key bypass and feedback pathways associated with either drug target and also results in enhanced efficacy in tumor models harboring KRASG12C mutations. We believe the data from […]
VBI Vaccines and Agenus Announce Collaboration to Evaluate VBI-1901 in Combination with Balstilimab in a Ph 2 Study in Primary Glioblastoma Patients
David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, commented, “GBMs are notoriously one of the most immunosuppressive solid tumors, which is why there are few effective treatment options. Based upon the encouraging data we have observed to date, we believe VBI-1901 has the potential to activate and boost specific T cell immunity capable of trafficking […]
Development of CYAD-101, Allogeneic TIM-based, NKG2D CAR T Candidate for Metastatic Colorectal Cancer (mCRC), to be discontinued
Based on a strategic, financial and medical review, taking into account the costs associated with the pursuit of the program and the delays to reach key medical milestones following the resolution of the previous Clinical Hold, the Company has decided to discontinue the development of CYAD-101 There were no new safety concerns leading to this […]
Enrollment Completed in Global Multi-Center Ph 3 Clinical Trial of Trilaciclib in Patients with mTNBC
“TNBC tumors are aggressive and difficult to treat; and while chemotherapy with or without targeted therapy remains first line TNBC standard of care, there is a great need to improve survival beyond that expected from it – particularly without increasing toxicity,” said Raj Malik, M.D., G1’s Chief Medical Officer. “PRESERVE 2 is exciting as it […]
Positive Topline Results Announced from Final PFS Analysis of BRUKINSA® (zanubrutinib) vs IMBRUVICA® (ibrutinib) in Ph 3 ALPINE trial in CLL patients
“This positive result adds to the growing body of evidence underpinning our belief in the potential for BRUKINSA to provide new hope for CLL patients facing this intractable disease. With this final PFS analysis, BRUKINSA has achieved superior progression free survival, as well as superiority in overall response rate versus ibrutinib,” said Mehrdad Mobasher, M.D., […]
U.S. FDA Accepts For Priority Review The sBLA For Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer
“Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last two years,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “People with pre-treated HR+/HER2- metastatic breast cancer who have progressed […]
US FDA grants Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with LUMAKRAS® (sotorasib)
“The survival rate following a diagnosis of NSCLC with a KRAS mutation is extremely poor. We are hopeful that by launching this clinical trial with Amgen, we may be able to fill the current gap in unmet medical need for these cancer patients,” said Frank McCormick, Ph.D., chairman of oncology at BridgeBio. “We are grateful […]
Exelixis Expands Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Include the Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Ph 1b STELLAR-002 Trial
“We are pleased to expand our agreement with Bristol Myers Squibb for the STELLAR-002 trial to include the novel fixed-dose combination of nivolumab and relatlimab to evaluate the potential benefit of combining XL092 with additional immune checkpoint inhibitors,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, […]
Autolus Therapeutics Announces Collaboration with Bristol Myers Squibb for Use of Autolus’ Proprietary Safety Switch System
“Safety switches are critical to the future of our field of advanced cell therapies. They allow us to develop approaches that are designed to significantly improve patient outcomes, whilst at the same time incorporating the potential to reduce the risk of severe adverse side effects from the treatment,” said Dr. Martin Pule, CSO of Autolus. […]
Ph 2 Clinical Trial of DNA-Damaging Agent PLX038 initiated in patients with Platinum-Resistant Ovarian Cancer
Drs. Hendrickson and Kaufmann stated, “We are excited to be able to bring this novel treatment to patients with relapsed, platinum-resistant ovarian cancer, in hopes of improving the outcome of this disease.” Added ProLynx co-founder and President Daniel V. Santi “Conventional short-acting topoisomerase 1 inhibitors have clinical activity in platinum-resistant ovarian cancer. Accordingly, we are […]
First Allogeneic CAR T Ph 2 ALPHA2 Trial of ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients initiated
“We are proud to initiate the industry’s first potentially pivotal Phase 2 trial for an allogeneic CAR T product. This milestone paves the road for both ALLO-501A and our broader pipeline of innovative products with the potential to greatly increase patient access to cell therapy,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and […]
TRITON3 Ph 3 Trial Of Rubraca® (Rucaparib) Achieves Primary Endpoint In Men With mCRPC With BRCA Or ATM Mutations
“We believe that the positive results from TRITON3 further demonstrate the important role that Rubraca can play as a treatment option for men with metastatic castration-resistant prostate cancer associated with homologous recombination deficiency, and we look forward to submitting these data to the regulatory authorities in the US during Q1 2023. Not only does this […]
Ph 3 TALAPRO-2 study of TALZENNA® + XTANDI® in mCRPC patients met its primary endpoint of rPFS compared with placebo plus XTANDI
“XTANDI is a global standard of care, with overall survival demonstrated in mCRPC, non-metastatic CRPC, and metastatic castration-sensitive prostate cancer (mCSPC),” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “We are very pleased with the strong findings from TALAPRO-2, and although no definitive conclusions can be made […]
FDA grants Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for 1L NSCLC
“We are pleased to receive this Fast Track designation as it acknowledges efti’s unique potential to empower the human immune system against cancer and significantly enhance patient responses to standard-of-care immunotherapy. Efti also offers a chemotherapy-free option for NSCLC patients in need of less toxic and more durable solutions,” stated Marc Voigt, CEO of Immutep.
FDA grants Fast Track Designation for Sapanisertib for the Treatment of NRF2-mutated Squamous Lung Cancer
“While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer. In addition, we know that patients with lung cancers that harbor mutations in the NRF2/KEAP1 pathway typically have poorer outcomes than those whose tumors do not have these mutations,” said Susan […]
