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 […]
Adagrasib +/- cetuximab demonstrates promising clinical efficacy and favorable tolerability in heavily pretreated CRC patients with KRASG12C mutation
“These exciting results further our understanding of the well-tolerated profile with robust and sustained responses that adagrasib provides as a monotherapy and in combination with cetuximab to patients with KRASG12C-mutated advanced colorectal cancer,” said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. “We are pleased about the significant […]
Kisqali® Adds One More Year Of Survival Benefit For Broadest Set Of Patients, Including Those With Aggressive HR+/HER2- Advanced Breast Cancer
“Patients who have visceral metastases typically have a worse prognosis and often demonstrate resistance to treatment, so as a clinician it is encouraging to see significant survival benefit with ribociclib in the first-line setting in patients with more aggressive disease,” said Denise A. Yardley, MD, Senior Investigator, Breast Cancer Research Program, Sarah Cannon Research Institute […]
Long-term data from the Ph 3 PRIMA study showed Zejula (niraparib) maintaining a sustained and clinically meaningful PFS benefit in 1L ovarian cancer patients
Hesham Abdullah, SVP, Global Head of Oncology Development, GSK said: “Patients can face a high risk of recurrence when diagnosed with late-stage ovarian cancer. The updated analysis of this study shows that Zejula can help patients potentially achieve a long-term remission.”
Lynparza +/- bevacizumab demonstrates clinically meaningful survival benefit in 1L advanced ovarian cancer across PAOLA-1 and SOLO-1 Ph 3 trials
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Historically the five year survival rate of newly diagnosed patients with advanced ovarian cancer is 30-50%. In that context, it is phenomenal to share the long term overall survival data from both PAOLA-1 and SOLO-1, with two out of three patients still alive in these trials. […]
Camrelizumab + Rivoceranib (Apatinib) Significantly Prolonged OS & PFS vs Sorafenib in Patients with uHCC in a Multinational Ph 3 Trial
“We and others have established the validity of immune-checkpoint inhibition for the treatment of HCC. The combination of camrelizumab plus rivoceranib phase 3 trial results demonstrate the combo treatment as a new first-line treatment option for uHCC,” said Dr. Lianshan Zhang, president of global R&D, Board Director of Hengrui Pharma. “We continue to work with […]
Results From Ph 3 LEAP-002 Trial of KEYTRUDA® + LENVIMA® Versus LENVIMA Monotherapy in Patients With uHCC presented
“The LEAP-002 trial reflects our research strategy to build on evolving standards of care to further improve outcomes for more people with unresectable hepatocellular carcinoma,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “The median overall survival of 21.2 months seen with KEYTRUDA plus LENVIMA provides critical insights for further research […]
Tislelizumab demonstrated efficacy and tolerability in 1L advanced liver cancer in Ph 3 RATIONALE 301 trial
“People living with advanced liver cancer face poor survival outcomes and frequently suffer from cirrhosis, which further complicates their treatment,” said Richard S. Finn, MD, professor of medicine, Department of Medicine, Division of Hematology/Oncology, David Geffen School of Medicine and Jonsson Comprehensive Cancer Center at UCLA and the lead US investigator on the trial. “These […]
DS-7300 Continues to Show Promising Durable Response in Patients with Several Types of Advanced Cancer
“These results represent important progress in the development of DS-7300, which is continuing to show promising durable efficacy in patients with several different types of advanced cancers, including lung, prostate or esophageal cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Based on these results, we are evaluating next steps for the clinical development […]
Interim clinical data of RLY-4008 from Ph 1/2 clinical trial in patients with FGFR2-altered CCA and multiple other solid tumors announced
“We are thrilled to be sharing interim RLY-4008 data from patients treated at the pivotal dose with the ESMO community,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “We believe the interim ORR of 88% for these patients helps to demonstrate the potential power of our Dynamo platform to build transformative therapies […]
Updated Findings from the Ph 2 SUMMIT Basket Trial of Neratinib for HER2-Mutant, Recurrent/Metastatic Cervical Cancer presented
“HER2 mutations are present in 5% of cervical cancers, most commonly in endocervical adenocarcinomas, and HER2 targeted therapy is a potential treatment option for patients whose cancer has grown after standard first lines of treatment, including platinum-based chemotherapy,” said Dr. Friedman, an investigator of the study from Memorial Sloan Kettering Cancer Center. “Neratinib treatment has […]
Patient-Reported Outcomes with Mirvetuximab vs Chemo in FORWARD I Study Reinforces Differentiated Tolerability Profile
“The data presented at ESMO continue to support mirvetuximab’s potential to displace single-agent chemotherapy in FRα-positive ovarian cancer and will serve as a guide as we seek to advance the broader development program,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. “With our biologics license application for mirvetuximab under Priority […]
Rubraca® (Rucaparib) As 1L Maintenance Treatment Improves PFS In Women With Advanced Ovarian Cancer Across Disease Risk Subgroups
“These additional results from the ATHENA-MONO analysis of the Phase 3 ATHENA trial demonstrate that rucaparib should be considered a new first-line maintenance treatment option for women with advanced ovarian cancer,” Dr. Kristeleit said. “In this analysis, rucaparib prolonged progression-free survival for patients with or without high risk factors for progression, irrespective of molecular characteristics, […]
KEYTRUDA + Chemo Showed Sustained OS Benefit vs Chemo Alone in in KEYNOTE-189 and KEYNOTE-407 trials for mNSCLC
“The overall survival findings from KEYNOTE-189 and KEYNOTE-407 changed the way patients with metastatic non-small cell lung cancer were treated and established KEYTRUDA plus chemotherapy as a foundational first-line treatment for this devastating disease,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “Now, with […]
Tagrisso demonstrated 5.5-year mDFS in the adjuvant treatment of patients with EGFR-mutated lung cancer
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: “It is remarkable that just two years ago, patients with early-stage EGFR-mutated lung cancer had no targeted treatment options after surgery. Now, around the world, patients have access to Tagrisso and its added benefit of protecting the brain and spinal cord. We look forward to mature […]
Imfinzi and tremelimumab with chemotherapy demonstrated sustained OS benefit in mNSCLC
Melissa Johnson, MD, Director of Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee, and a lead investigator in the POSEIDON Phase III trial, said: “Metastatic non-small cell lung cancer is a devastating diagnosis, particularly for patients whose cancers are less responsive to standard treatments such as chemotherapy and immune therapy. […]
Enhertu continues to demonstrate clinically meaningful tumour response in patients with HER2-mutant mNSCLC
Cristian Massacesi, Chief Medical Officer & Oncology Chief Development Officer, AstraZeneca, said: “The clinically meaningful activity, together with the favourable safety profile seen in the DESTINY-Lung02 trial helps establish the optimal dose of Enhertu at 5.4 milligrams per kilogram in previously-treated HER2-mutant non-small cell lung cancer. As we continue to explore the potential of this […]
Trifluridine/tipiracil + bevacizumab showed a statistically significant OS improvement vs trifluridine/tipiracil alone in Ph 3 trial in mCRC patients
“Findings from the SUNLIGHT trial could potentially represent a significant advancement in the treatment of patients with metastatic colorectal cancer who have progressed after two lines of standard chemotherapy,” said Nadia Caussé-Amellal, M.D., Head of Global Development, GI Indications, Oncology and Immuno-Oncology Therapeutic Area, Servier. “Combining trifluridine/tipiracil with bevacizumab demonstrated the potential to extend survival […]
Positive Initial Ph 2 Data in Late-Line Solid Tumor Patients Treated With KRAS-Directed Immunotherapy (SLATE) announced
“We are highly encouraged by the early signs of efficacy from the SLATE immunotherapy program, in particular, from our product candidate targeting multiple KRAS oncogenic mutations in patients with advanced, treatment-refractory disease (SLATE-KRAS),” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone. “We observe molecular responses in approximately 40% of all […]
Positive data announced from multiple expansion cohorts of Ph 1 trial of fianlimab and Libtayo® (cemiplimab) in advanced melanoma
“After regulatory approvals of our PD-1 inhibitor Libtayo in two advanced non-melanoma skin cancers, we are expanding our efforts in dermato-oncology to address advanced melanoma,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “Combining LAG-3 and PD-1 inhibition has shown promise in advanced melanoma but achieving response rates […]
Positive early data announced for ubamatamab (REGN4018; MUC16xCD3) in recurrent ovarian cancer and REGN5093 (METxMET) in MET-altered advanced NSCLC
“Bispecific antibodies are an important component of our oncology pipeline because of their flexibility to potentially address a variety of cancers,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “At ESMO, we’re showcasing this flexibility with ubamatamab and REGN5093, two novel bispecific antibodies that are initially being investigated […]
Positive Neoadjuvant Libtayo® (cemiplimab) Monotherapy Data in Resectable CSCC Published in NEJM
“Regeneron conducted the first pivotal trial of Libtayo in advanced cutaneous squamous cell carcinoma that was unlikely to be curable by surgery or radiation, and we are now studying the utility of Libtayo in earlier stages of this disease. In addition to our neoadjuvant trial, a global Phase 3 trial of Libtayo is ongoing in […]
Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA and PADCEV as Monotherapy in 1L Advanced Urothelial Cancer
“Results from EV-103/KEYNOTE-869 Cohort K support the ongoing investigation of enfortumab vedotin and pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who are in need of treatment options, and this combination may be an important therapeutic option for these patients,” said Jonathan E. Rosenberg, M.D., Chief, Genitourinary Medical Oncology Service, Division of […]
Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “For the first time, patients in the US with advanced biliary tract cancer have an immunotherapy-based treatment option that meaningfully extends survival and is well-tolerated. This approval for Imfinzi and chemotherapy advances our ambition to challenge treatment expectations and transform care for patients with gastrointestinal […]
AB Science submits Application to EMA for Conditional Marketing of Masitinib for the treatment of ALS
Application for Conditional Marketing Authorization to European Medicines Agency (EMA) by AB Science for Masitinib for the treatment of ALS. The application now validated by EMA was submitted based on the results of the phase II/III AB10015 study. The AB10015 trial was conducted on 394 ALS patients over 48 weeks as a randomized double-blind placebo-controlled […]
Phase 2a clinical trial data for COYA-101 in ALS announced
“We believe this Phase 2a study, with the limitations of a small sample size, supports that COYA 101 was well tolerated and biologically active in ALS patients and may slow or halt disease progression in the right patient population. We believe the findings that high levels of inflammation and oxidative stress may limit the effectiveness […]
Amydis receives NIH Grant Award to develop a novel TDP-43 retinal tracer for ALS patients
Dr. Clive Svendsen, Executive Director of the Cedars-Sinai Board of Governors Regenerative Medicine Instiute and a consultant on the grant said that “the ability to detect and monitor TDP-43 at micron-level precision in CNS tissue could significantly facilitate regenerative medicine research focused on slowing progression of ALS and FTD.” On the other hand, Dr. Stella […]
Submission of New Drug Application to the FDA for the treatment of Parkinson’s Disease
Amneal Pharmaceuticals Inc. has submitted a new drug application for the treatment of Parkinson’s Disease to the U.S. Food and Drug Administration (FDA). The new drug IPX203, is a novel oral formulation of carbidopa/levidopa capsules for patients suffering from Parkinson’s Disease (PD). The submission was initiated based on the promising data received from the RISE-PD […]
BrainVectis receives clearance to conduct Phase I/II clinical trial for early-stage Huntington’s Disease
BrainVectis, an AskBio subsidiary, has received clearance to conduct the Phase I/II clinical trial for Huntington’s disease (HD) gene therapy BV-101 in France. BV-101, a novel adeno-associated virus gene therapy vector helps in the clearance of the mutant huntingtin protein in the diseased condition. BV-101 has been shown to provide neuroprotection and restore the function […]
First Patient Dosed In Ph 1/2 Study Of FPI-1966 In Patients With Advanced Solid Tumors Expressing FGFR3
“Dosing of the first patient in this Phase 1/2 study of FPI-1966 demonstrates our continued ability to bring innovative targeted alpha therapies (TATs) into the clinic,” said Chief Executive Officer John Valliant, Ph.D. “This study will evaluate FPI-1966 in patients with solid tumors expressing FGFR3, a validated cancer target found in multiple tumor types with […]
