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 […]
IND Submission Announced for GTB-3650 for Treatment of CD33+ Leukemia
“Today’s announcement is an important milestone for GT Biopharma, and we look forward to advancing GTB-3650 for treatment of CD33+ leukemia. We are excited to expeditiously move this molecule into the clinic as we execute on our clinical objectives in 2024,” stated Michael Breen, GT Biopharma’s Executive Chairman, Board of Directors and Interim Chief Executive […]
TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer
“TAR-200 represents a novel interventional approach for the treatment of localized bladder cancer where today, unfortunately, options are limited and include antiquated BCG therapy or radical cystectomy,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “This Breakthrough Therapy Designation recognizes TAR-200 as a promising advancement and marks an […]
FDA Accepts for Priority Review Application for Opdivo + Cisplatin-Based Chemo for the 1L Treatment of Adult Patients with Unresectable/Metastatic urothelial carcinoma
“The FDA’s acceptance of our application for Opdivo in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma. There remains a clear need for efficacious first-line treatment options that may potentially help improve outcomes for patients […]
FDA granted “Fast-Track” Designation for Novel Armed Nanocell Drug Conjugate (ANDC) Pancreatic Cancer Therapeutic EDV (EnGeneIC Dream Vector)
EnGeneIC’s CEO, Dr. Himanshu Brahmbhatt is enthusiastic about the FDA’s “Fast-Track”, stating, “This approval is a testament to the potential impact of our EDV-based ANDC in addressing the urgent needs of patients with metastatic PDAC. We are committed to expeditiously advancing our clinical program for PDAC patients and others with low survival cancers. These are […]
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 […]
Encouraging Initial Data from Randomized SELECT-AML-1 Phase 2 Clinical Trial Evaluating Tamibarotene in Combination with Venetoclax and Azacitidine Announced
“I am highly encouraged by the initial data from the randomized portion of SELECT-AML-1,” said Thomas Cluzeau, MD, PhD, Head of Hematology at Nice University Hospital, Côte d’Azur University in France. “Despite the recent advances in treatment for unfit AML patients, there remains a substantial need for options that offer higher response rates and improved […]
Interim Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) Announced
“We are thrilled to see this level of clinical activity in such a heavily pre-treated patient population,” said John Houston, Ph.D., chairperson, chief executive officer, and president at Arvinas. “Vepdegestrant is the only PROTAC® ER degrader in late-stage clinical development. The results from this trial evaluating vepdegestrant in combination with palbociclib help advance our goals […]
Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of PFS in patients with newly diagnosed multiple myeloma not eligible for transplant
Thierry Facon, MD, Professor of Haematology in the Department of Haematology, Lille University Hospital, Lille, France, member of French Academy of Medecine and IMROZ Principal Investigator said, “The IMROZ trial outcome is promising for patients with newly diagnosed multiple myeloma who are transplant-ineligible, as there remains a significant unmet need for potential new therapies. First […]
Interim Data from Phase 1b/2 Clinical Trial of Nana-val in Patients with EBV+ve Solid Tumors Show Confirmed Tumor Responses at Higher Dose Levels
“The initial efficacy, safety, and pharmacokinetic data from the first five dose cohorts of the Phase 1b trial in patients with recurrent or metastatic EBV-positive NPC are very encouraging,” said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta. “These results support the continued advancement and dose escalation of the study, especially given the […]
Interim Data Presented from Two Ongoing Phase 2 Clinical Trials with Vebreltinib in NSCLC Patients with MetExon14 Skipping Mutation
“For the first time, we report the ORR of vebreltinib by GCN in NSCLC patients with MetExon14 skipping mutation. Similar efficacy analyses by GCN subgroup of other cMET inhibitors are either not readily available publicly or were reported to have lower ORR in NSCLC patients with MetExon14 skipping mutation alone without overlapping MET amplification. We […]
FAILED TRIAL: CERPASS Clinical Trial of RP1 + cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma did not meet primary endpoints
“The overall data from the CERPASS study indicate that treatment with RP1 in combination with cemiplimab led to clinically meaningful activity with a higher rate of complete responses and favorable duration of response versus cemiplimab alone.” said Philip Astley-Sparke, CEO of Replimune.
Encouraging Initial Data from Randomized SELECT-AML-1 Phase 2 Clinical Trial Evaluating Tamibarotene in Combination with Venetoclax and Azacitidine Announced
“I am highly encouraged by the initial data from the randomized portion of SELECT-AML-1,” said Thomas Cluzeau, MD, PhD, Head of Hematology at Nice University Hospital, Côte d’Azur University in France. “Despite the recent advances in treatment for unfit AML patients, there remains a substantial need for options that offer higher response rates and improved […]
Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma
“Multiple myeloma remains an incurable disease, in which patients endure cycles of relapse and remission, resulting in a critical need for innovative medicines,” said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Hematology at Regeneron. “With longer follow-up data on linvoseltamab, we’re seeing deep and durable responses with a complete response […]
Phase 3 CheckMate -8HW Trial Evaluating Opdivo + Yervoy vs Chemo in MSI-H or MRD Metastatic Colorectal Cancer Meets Primary endpoint
“The benefits of Opdivo plus Yervoy in MSI-H/dMMR mCRC were established previously in CheckMate -142, in which the dual immunotherapy combination demonstrated strong and durable anti-tumor activity among patients who had progressed after prior fluoropyrimidine-based combination chemotherapy,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “Now, […]
Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence in patients with early breast cancer; supports regulatory submissions
“The final iDFS analysis of NATALEE represents a significant milestone, building upon the robust evidence supporting Kisqali as a potential new adjuvant treatment for a broad, clinically common and identifiable population of patients with stage II and III HR+/HER2- early breast cancer,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. […]
Inavolisib combination reduces the risk of disease progression by 57% in people with advanced HR+ve, HER2-neg breast cancer with a PIK3CA mutation
“The importance of the PI3K pathway has long been recognised across many cancers, and inavolisib could transform the way breast cancer is treated in patients whose tumours harbour PIK3CA mutations,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The clinically meaningful benefit observed with the inavolisib combination speaks […]
Kadcyla shows significant OS benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment
“We are pleased that Kadcyla could offer people with HER2-positive early breast cancer with a particularly poor prognosis a chance to live longer and without recurrence of their disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The ultimate goal of treating early breast cancer is to maximise […]
Findings from Phase 2 KeyVibe-002 Trial of Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with mNSCLC Announced
“This study was designed to evaluate a coformulation of vibostolimab and pembrolizumab in a population of patients who are heavily pre-treated and have progressed following treatment with standard of care therapies, often leaving them with limited treatment options and a poor prognosis,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We […]
New Positive Interim Data from Dose Escalation and Phase 2 Expansion Cohorts of Zotatifin in ER+ Metastatic Breast Cancer Patients Announced
“We are extremely pleased with the positive interim data, especially the 7.4 month mPFS in the ZFA cohort of heavily pretreated patients, which builds on the responses reported earlier and underscores the potential of zotatifin as a promising treatment option for patients with ER+ metastatic breast cancer,” said Steve Worland, Ph.D., president and chief executive […]
New Data Show Durable Response Following Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg)
“These new data continue to build on the body of evidence supporting the efficacy and safety of ADSTILADRIN, adding to the data on its sustained durable response following treatment,” said Elizabeth Garner, M.D., M.P.H., Chief Scientific Officer, Ferring Pharmaceuticals, U.S. “Patients with BCG-unresponsive NMIBC are at high risk for recurrence and disease progression, which can […]
Successful Completion and Interim Results of Phase 1 Study of HC-5404 in Solid Tumors announced
“We are excited to announce the successful completion of our Phase 1 monotherapy study of HC-5404 along with the two publications in Clinical Cancer Research,” said Jonathan Lanfear, President and CEO. “We are encouraged by the safety profile, dose-dependent exposure, and pathway engagement, as well as the preliminary signals of efficacy observed in our Phase […]
Data from Phase 1/2 APEX-01 Dose Escalation Study of ARX517 in mCRPC announced
“We continue to observe no DLTs or SAEs at the highest ARX517 dose tested. We believe this is a direct result of the stability of conjugation supported by PK data presented at ESMO last month. While we are opportunely positioned to explore higher doses, we have already observed significant PSA50 decline and long duration on […]
Positive results from DREAMM-7 head-to-head phase III trial for Blenrep in relapsed/refractory multiple myeloma announced
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible and have novel mechanisms of action. We are particularly encouraged by the potential for belantamab mafodotin when combined with BorDex to address high unmet need in relapsed/refractory multiple myeloma, […]
Phase 1 Study Evaluating Ampligen® as a Component of a Chemokine-Modulating (CKM) Regimen in mTNBC
“CD8+ T cells are an important prognostic and predictive biomarker for clinical outcomes in breast cancer, and our findings showing that CKM can modulate the tumor microenvironment are intriguing,” says Dr. Gandhi. “We expect that this work will pave the way for future studies to further understand and improve responses to checkpoint inhibitors in patients […]
New Preliminary OS data in Selinexor-Treated Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer as Part of Pre-Specified Exploratory Subgroup Analysis of the SIENDO Study Announced
“The preliminary OS data from this exploratory subset analysis of the SIENDO study corroborate the PFS results observed, which is compelling in this novel biomarker-driven population with high unmet need,” said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. “These results showcase selinexor’s potential as a foundational treatment for patients with TP53 wild-type endometrial […]
Efficacy and Safety Data of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Heavily Pretreated Patient Population Announced
“Patients with recurrent LGSOC currently have no medicines approved by the U.S. Food and Drug Administration and limited treatment options for their disease,” said Rachel Grisham, M.D., Section Head, Ovarian Cancer and Director, Westchester Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center N.Y., and the lead U.S. investigator of RAMP 201. “The results from […]
