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
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 […]
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.”
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 […]
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 […]
FDA Approves KEYTRUDA for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemo as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery
“There remains a need for treatment options to improve outcomes for patients with earlier stages of non-small cell lung cancer,” said Dr. Heather Wakelee, principal investigator for KEYNOTE-671, thoracic medical oncologist and professor of medicine at Stanford University and past president of the International Association for the Study of Lung Cancer (IASLC). “This important milestone […]
European Commission Approves KEYTRUDA as Adjuvant Treatment for Adults With NSCLC at High Risk of Recurrence Following Complete Resection & Platinum-Based Chemo
“In the unfortunate scenario that non-small cell lung cancer recurs after surgery, most patients have to face limited palliative treatment strategies, underscoring the need to improve treatment outcomes for earlier stages of NSCLC,” said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. “This approval of […]
