KEYTRUDA Significantly Improved OS Versus Placebo as Adjuvant Therapy for Certain Patients With RCC Following Nephrectomy
“As we continue to evaluate the potential of KEYTRUDA in earlier stages of disease across multiple types of cancer, we hope to reduce disease recurrence and ultimately, improve overall survival outcomes,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “These new results from KEYNOTE-564 are […]
Phase III RUBY trial of Jemperli (dostarlimab) plus chemotherapy meets endpoint of OS in patients with primary advanced or recurrent endometrial cancer
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “With today’s headline results from Part 1 of the phase III RUBY trial, dostarlimab plus chemotherapy has become the only immuno-therapy combination to show a survival benefit in this broader patient population in this treatment setting. We look forward to sharing detailed results of […]
Initial Phase 2 Clinical Data on Its Personalized Cancer Vaccine EVX-01 Announced
Christian Kanstrup, CEO of Evaxion, stated, “We firmly believe that our AI-Immunology™ platform has the potential to revolutionize the field of oncology and infectious diseases. Today’s update underscores its promise in immuno-oncology, with our EVX-01 vaccine safely eliciting robust immune responses in all patients. Notably, a pronounced tumor reduction in a metastatic patient with initial […]
FDA Approves KEYTRUDA + Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
“Cancers of the biliary tract can be highly aggressive tumors, underscoring the need for additional treatment options for the growing number of patients facing this challenging disease,” said Dr. Robin Kate Kelley, professor of clinical medicine in the division of hematology/oncology, University of California, San Francisco. “Today’s approval of pembrolizumab in combination with chemotherapy offers […]
Caris Life Sciences and Moderna Announce Multi-Year Strategic Partnership to Advance mRNA-Based Oncology Therapeutics
“We are thrilled to partner with Moderna to impact and advance the field of cancer treatment with mRNA medicines, with a common goal of improving patient lives,” said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. “The aggregate strength of our combined molecular, data science and therapeutics technologies will support the predictive modeling […]
GSK enters exclusive license agreement with Hansoh for HS-20089
Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: “Given early clinical data, we believe that HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours. This agreement is in line with our approach to advancing novel treatment options for patients with gynaecologic cancers.”
Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers
“We have been working hard to increase the capacity and improve the reliability of the supply of our radioligand therapies to ensure patients have access to this therapy and to prepare for future growth as more patients may become eligible for this treatment,” said Victor Bulto, President, Novartis US. “Radioligand therapies have the potential to […]
FDA Granted Fast Track Designation for ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer
“The receipt of Fast Track designation for ONCT-534 supports our belief that patients with mCRPC who relapse after treatment with ARPIs such as enzalutamide or abiraterone, represent an important unmet medical need,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We believe that due to ONCT-534’s novel mechanism of action, it may address important […]
Resubmission of BLA for N-803 + BCG for the treatment of BCG-unresponsive NMIBC accepted; new PDUFA date of April 23, 2024
“We are pleased that the FDA has accepted ImmunityBio’s resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission. We look forward to working closely with the Agency to finalize the review and to bringing this important immune-enhancing therapeutic to patients suffering from bladder cancer,” said Patrick Soon-Shiong, […]
EMA accepted the MAA for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with FRα-positive, platinum-resistant epithelial ovarian cancer
“The acceptance of our MAA is another important regulatory milestone in the next chapter of ELAHERE’s story as we work diligently to deliver this new treatment option to patients with platinum-resistant ovarian cancer globally,” said Michael Vasconcelles, MD, ImmunoGen’s Executive Vice President, Research, Development, and Medical Affairs. “As the first novel medicine to have demonstrated […]
Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced NSCLC
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Understanding the molecular drivers behind a lung cancer diagnosis is critical, and while there are now targeted options for many patients, those with HER2-mutant non-small cell lung cancer have had few treatment options, none of which have been approved to treat their specific type of […]
FDA approves LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
“LOQTORZI’s first approval is a pivotal event for Coherus as an innovative oncology company. As a next generation PD-1 inhibitor it is the keystone of our I-O strategy to extend cancer patient survival as shown with the impressive results in NPC,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. “We are particularly excited […]
Natera’s evolution in molecular diagnostics
Natera’s success traces to pioneering research isolating and analyzing fetal DNA fragments circulating in a pregnant woman’s bloodstream. Natera capitalized on the emerging space of non-invasive prenatal tests (NIPT) with products such as Panorama that represented a major advance over risky amniocentesis procedures used for definitive diagnosis. Commencing its journey in the NIPT space as […]
CONFERENCE COVERAGE: ESMO 2023
Daiichi Sankyo and Merck Announce Global Development and Commercialization Collaboration for Three Daiichi Sankyo DXd ADCs
“The promising results from clinical trials of patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan continue to demonstrate the broad applicability of Daiichi Sankyo’s DXd ADC technology across multiple targets, with each of these medicines having the potential to change clinical practice as has been already seen with ENHERTU®,” said Sunao Manabe, Representative Director, Executive Chairperson […]
Ascentage Pharma and AstraZeneca Enter into Clinical Collaboration on the Registrational Phase III Study of Bcl-2 Inhibitor Lisaftoclax in Combination with BTK Inhibitor Acalabrutinib in Patients with First-Line CLL/SLL
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, “Combining Bcl-2 inhibitors and BTK inhibitors as a therapeutic approach has long attracted interest from both the research community and the industry. The Bcl-2 inhibitor lisaftoclax is a key drug candidate in Ascentage Pharma’s apoptosis-targeted pipeline. Results from the global Phase II study of lisaftoclax […]
Mablink Bioscience Enters an Agreement to be Acquired by Lilly
Jean-Guillaume Lafay, Mablink’s Chief Executive Officer, stated: “Mablink’s agreement to be acquired by Lilly is a strong endorsement of our approach, our technology and our team. The values we share with Lilly, and our combined expertise are also a unique opportunity to leverage Mablink’s capabilities and endeavors to potentially bring transformative therapies to cancer patients […]
Antiverse and GlobalBio, Inc. extend collaboration to advance antibody cancer therapeutics
Ben Holland, Co-founder and CTO of Antiverse, said: “This agreement further validates our AI-driven drug discovery platform, successfully generating a panel of anti-PD-1 antibodies, with at least two potential candidates entering preclinical development. Through these innovative collaborations, Antiverse strives to accelerate the identification and development of novel antibody therapeutics for cancer, reducing drug discovery timelines […]
Elevar Therapeutics & Jiangsu Hengrui Pharma Announce Global Commercialization Licensing Agreement for Camrelizumab + Rivoceranib for uHCC
“This agreement will boost our companies’ shared focus on advancing the standard of care in uHCC, as having both camrelizumab and rivoceranib under one portfolio will significantly streamline commercialization,” said Saeho Chong, Elevar chief executive officer. “In our investigational Phase 3 CARES-310 study, the combination was shown to provide the highest reported median overall survival […]
Phanes Therapeutics, Inc. Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate PT886 in Combination with KEYTRUDA
“Phanes is very excited about partnering with Merck on this novel approach to treat patients with gastric or gastroesophageal cancers,” said Dr. Ming Wang, Founder and CEO of Phanes. “Claudin 18.2 is a clinically validated target and is over-expressed in these types of GI tumors. We believe the mechanisms of PT886 and pembrolizumab are complementary […]
First Patient Dosed in the Registrational Phase III Study of Olverembatinib in Treatment-Naïve Patients with Ph+ ALL
Prof. Weili Zhao, Vice President of Shanghai Jiaotong University School of Medicine Affiliated Ruijin Hospital and Director of Shanghai Institute of Hematology, commented, “Ph+ ALL used to be the most high-risk and difficult-to-treat subtype of leukemia and the introduction of TKIs has resulted in improved prognosis to patients with this condition. However, clinicians face the […]
First Patient Cohort dosed in Ovarian Cancer CER-T Clinical Trial
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, “We are pleased with the positive safety data from the first cohort and look forward to advancing to the next higher dose cohort. We hope to continue observing good safety results as we continue to increase dosage, and eventually objective efficacy data.”
First Patient Dosed in Phase 1/2 Study of BDC-3042 in Patients with Advanced Cancers
“We are excited to have dosed the first patient in this first-in-human clinical trial, which will evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BDC-3042 in a diverse set of advanced cancers,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. “BDC-3042 is a monoclonal antibody that repolarizes tumor-associated macrophages (TAMs) to […]
First Patients Dosed in First-in-Human Phase 1 Clinical Study of FX-909 in Advanced Solid Malignancies, Including Urothelial Cancer
“We are excited to announce the dosing of patients in the first dose cohort of our Phase 1 clinical study of FX-909, marking a major milestone for Flare Therapeutics as we transition to a clinical-stage company,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Flare Therapeutics. “Rooted in innovation and expertise in transcription […]
Ph 3 CheckMate-67T Trial of Subcutaneous Nivolumab (nivolumab and hyaluronidase) Meets Co-Primary Endpoints in Advanced or Metastatic ccRCC
“Intravenous Opdivo has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. “We are delighted that the results […]
New Data Demonstrating Superiority of TPST-1120 Arm Across Multiple Study Endpoints in Randomized First-Line HCC Study Released
“This comprehensive analysis of more mature clinical data shows an even greater benefit than the earlier interim analysis of the TPST-1120 triplet therapy over standard of care alone, both for the entire study population and in subpopulations of patients, the latter of which was predicted by TPST-1120’s proposed mechanism of action,” said Stephen Brady, president […]
Interim PK/PD and Clinical Data for MRT-2359 in Phase 1/2 Trial for MYC-Driven Solid Tumors announced
“We’re highly encouraged by the safety profile, the depth of pharmacodynamic modulation of GSPT1 in tumors, and even more so by the early evidence of anti-tumor activity of MRT-2359 in patients with biomarker-positive cancers,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “We believe these results, the first ever to show clinical […]
Positive Initial Topline Phase 2a Data of SLS009 in AML announced
“This outcome may represent a long-awaited breakthrough in treating patients refractory to venetoclax combination therapies after multiple lines of treatment,” said Dr. Omer Jamy, a principal investigator in the study and Assistant Professor of Medicine at the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB) and Associate Director of the Bone […]
Tagrisso plus chemo granted Priority Review in the US for patients with EGFR-mutated advanced NSCLC
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The FLAURA2 results reinforce Tagrisso as a backbone of standard of care in 1st-line EGFR-mutated non-small cell lung cancer, providing patients with an additional nine months of median progression-free survival when combined with chemotherapy. This option is particularly important for patients with a poorer prognosis such […]
Positive CHMP opinion recommending approval of Jemperli (dostarlimab) + chemo as 1L treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “We are pleased with this positive CHMP opinion and the potential for dostarlimab with chemotherapy to treat patients with this very challenging form of endometrial cancer. If approved, dostarlimab plus chemotherapy will be the first new treatment option in decades for these patients in […]
