mRNA-4157 (V940) + KEYTRUDA Combination Demonstrated Continued Improvement in RFS and DMFS in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA At Three Years
“As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology. “These data add another […]
Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma
“This orphan drug designation highlights the urgent need for new targeted treatment options for patients with rare diseases such as nasopharyngeal carcinoma, which is highly associated with EBV,” said Mark Rothera, President and Chief Executive Officer of Viracta. “We are encouraged by the interim data from the Phase 1b/2 study of Nana-val in patients with […]
FDA grants priority review for tarlatamab in SCLC
“The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “While first-line treatments often show strong responses, patients can experience aggressive recurrences […]
FDA Approves WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI
“Despite recent progress in the treatment of advanced RCC, there is yet to be an option specifically approved for patients whose disease progresses following a PD-1 or PD-L1 inhibitor and a TKI therapy,” said Dr. Toni K. Choueiri, LITESPARK-005 study chair, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg […]
FDA Approves Expanded Indication for KEYTRUDA Plus Padcev for 1L Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer
“Advanced bladder cancer is a common cause of cancer-related death,” said Dr. Thomas Powles, primary investigator of KEYNOTE-A39, professor of Genitourinary Oncology and director, Barts Cancer Center. “The overall survival benefit seen in the KEYNOTE-A39 trial demonstrates the potential for KEYTRUDA in combination with enfortumab vedotin to impact the first-line treatment of patients with locally […]
Foundation Medicine
Foundation Medicine stands as an early innovator, harnessing genomics technologies for scalable, high-throughput cancer gene mutation profiling-based diagnoses. Established in 2010 in Cambridge, Massachusetts, the company’s first product, FoundationOne, was launched in 2012 as a tissue-based test. This was followed by FoundationOne Heme in 2013, an NGS based comprehensive genome profiling test catering to hematologic […]
IDEAYA Announces Clinical Study Collaboration with Gilead Sciences to Evaluate Trodelvy® and IDE397 Combination in MTAP-Deletion Bladder Cancer
“We are delighted to enter into this clinical collaboration with Gilead that advances our multi-pronged strategy designed to deliver maximal benefit to MTAP-deletion solid tumor patients. We believe the strong mechanistic rationale of this combination, and the monotherapy efficacy observed by both agents in MTAP-deletion bladder cancer, may enable this combination to be differentiated and […]
Exelixis and Arcus Biosciences Announce Clinical Trial Collaboration to Evaluate Zanzalintinib in Combination with AB521 in Patients with Advanced RCC
“We are excited to learn more about the potential effects of zanzalintinib plus Arcus’ HIF-2⍺ inhibitor, as these two molecules approach the inhibition of cancer cell proliferation and tumor angiogenesis from differing angles, and combination therapy may provide better outcomes than either therapy alone,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical […]
First Patient Enrolled in Phase 2 Clinical Study Evaluating BDC-1001 in Patients with HER2-Positive Breast Cancer Previously Treated with Enhertu
“The dosing of the first patient in this trial is a significant achievement in our efforts to find new treatment options for patients with HER2-positive breast cancer that continues to progress after treatment,” said Kang, a principal investigator on the study. “Despite the numerous HER2-targeted therapeutics approved for treating advanced or metastatic HER2-positive breast cancer, […]
STELLAR-305 Phase 2/3 Pivotal Trial of Zanzalintinib + Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer announced
“We are excited to progress zanzalintinib, our next-generation multi-targeted tyrosine kinase inhibitor, into this population of patients who otherwise are relegated to immunotherapy plus chemotherapy, but may benefit from a chemo-free option,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “This study is based on encouraging […]
FDA Grants Priority Review of sBLA for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer
“With the FDA’s filing of our sBLA, we are one step closer to securing full approval of ELAHERE in the US and establishing this novel ADC as the standard of care in FRα-positive platinum-resistant ovarian cancer,” said Michael Vasconcelles, MD, ImmunoGen’s Executive Vice President, Research, Development, and Medical Affairs. “This regulatory milestone, achieved just over […]
Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
“Receiving both FDA Fast Track and Breakthrough Therapy Designation is an important milestone in the development of cretostimogene grenadenorepvec and for patients with bladder cancer who urgently need more therapeutic options,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “We are encouraged by this momentum following our recent announcement of first results from […]
Abecma Becomes First CAR T Approved for Use in Earlier Lines of Therapy for Patients with Relapsed or Refractory Multiple Myeloma in Japan
Commenting on the approval, Makoto Sugita, Bristol Myers Squibb’s head of R&D in Japan, said, “Multiple myeloma is an intractable disease with recurrent relapses that are difficult to cure with existing therapies. Treatment options for patients with RRMM are limited, and we are pleased that Abecma is the first CAR T cell therapy to be […]
KEYLYNK-008 Trial of KEYTRUDA + LYNPARZA for Patients With Metastatic Squamous NSCLC to Stop for Futility
“While there have been significant scientific advancements in lung cancer research in recent years, unmet needs remain for patients with advanced non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “We sincerely thank the patients and investigators for their participation in this […]
FAILED TRIAL: Phase 3 LEAP-001 Trial Evaluating KEYTRUDA + LENVIMA as 1L Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma did not meet primary dual endpoints
“We remain confident in the proven benefit of KEYTRUDA plus LENVIMA for the treatment of appropriate patients with certain types of previously treated advanced endometrial carcinoma based on results from the KEYNOTE-775/Study 309 trial and will continue to research the KEYTRUDA plus LENVIMA combination in patients with other types of difficult-to-treat cancers,” said Dr. Gregory […]
Exact Sciences
Exact Sciences was founded in 1995 with the visionary, and perhaps ahead of its time goal of developing non-invasive colorectal cancer (CRC) testing. The company’s early and innovative stool-DNA tests like PreGen-Plus faced financial struggles and regulatory headwinds. The turning point was the 2009 collaboration with the Mayo Clinic for licensing the stool DNA test […]
Aquinnah’s potential Alzheimer’s drug capable of reducing ~70% brain tau pathology
Aquinnah Pharmaceuticals recently announced the preclinical findings on its novel therapeutic designed to slow or stop the progression of Alzheimer’s Disease (AD) and related disorders. Their drug discovery relies on identifying compounds capable of eliminating persistent stress granules. Stress granules are aggregates of proteins and RNA molecules formed as a cell survival process in response to […]
CONFERENCE COVERAGE: 2023 SITC Annual Meeting
Karyopharm Announces Clinical Trial Collaboration with BMS to Evaluate CELMoD Agent CC- 92480 Mezigdomide + Selinexor in Patients with R/R Multiple Myeloma
“This is an important collaboration with Bristol Myers Squibb to explore this novel and entirely oral combination in patients who have progressed following T-cell engaging therapy. This trial will also evaluate mezigdomide-selinexor plus dexamethasone in patients with relapsed/refractory multiple myeloma who need an effective alternative to T-cell therapies,” said Richard Paulson, MBA, President and Chief […]
Prelude Therapeutics and AbCellera Enter Partnership to Develop First-in-Class Precision ADCs in Oncology
“We made significant progress in the third quarter with our four clinical stage molecules and, as planned, conducted a rigorous assessment of each program. Based on this assessment, we are prioritizing our resources on our first-in-class SMARCA2 degrader molecules, IV and oral, and our potential best-in-class CDK9 inhibitor program,” stated Kris Vaddi, Ph.D., Chief Executive […]
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 […]
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.”
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, […]
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
