Journal of Clinical Oncology

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Monday, April 3, 2023
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Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • This marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate in the U.S. in these patients.
  • At baseline, 97.5% of patients had metastatic urothelial cancer and 2.5% of patients had locally advanced urothelial cancer.
  • In KEYNOTE-869, the safety of KEYTRUDA in combination with enfortumab vedotin was investigated in patients with locally advanced or metastatic urothelial carcinoma and who are not eligible for cisplatin-based chemotherapy.

Deciphera Pharmaceuticals Announces QINLOCK® Included in NCCN Guidelines® for the Treatment of Second-Line GIST Patients and FDA Grants Breakthrough Therapy Designation for QINLOCK in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18

Retrieved on: 
Tuesday, March 14, 2023
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“The Breakthrough Therapy Designation reflects the substantial clinical benefit of QINLOCK in second-line GIST patients harboring mutations in KIT exon 11 and 17/18 that we observed in the ctDNA analysis from the INTRIGUE Phase 3 study.

Key Points: 
  • “The Breakthrough Therapy Designation reflects the substantial clinical benefit of QINLOCK in second-line GIST patients harboring mutations in KIT exon 11 and 17/18 that we observed in the ctDNA analysis from the INTRIGUE Phase 3 study.
  • If approved, we believe QINLOCK has the potential to become the standard-of-care for this group of second-line GIST patients around the world.
  • Patient reported outcome measures also showed a more favorable tolerability profile for patients receiving QINLOCK compared to patients receiving sunitinib.
  • Patients with mutations in KIT exon 11 and exon 17/18 only (n=52) derived substantially improved clinical benefit with QINLOCK versus sunitinib.

2seventy bio Announces Appointment of Wei Lin, M.D. to Board of Directors

Retrieved on: 
Wednesday, March 8, 2023
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2seventy bio, Inc. (Nasdaq: TSVT) today announced the appointment of Wei Lin, M.D.

Key Points: 
  • 2seventy bio, Inc. (Nasdaq: TSVT) today announced the appointment of Wei Lin, M.D.
  • to the company’s Board of Directors, effective immediately.
  • “We are thrilled to welcome Dr. Wei Lin to 2seventy’s Board during an exciting time in our Company’s growth,” said Nick Leschly, chief kairos officer.
  • “Unleashing the power of the T cell is a truly inspiring scientific mission.

Cardiff Oncology Announces the Appointment of Fairooz Kabbinavar, MD, FACP, as Chief Medical Officer

Retrieved on: 
Thursday, February 2, 2023
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SAN DIEGO, Feb. 2, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today announced that it has strengthened its leadership team with the appointment of Fairooz Kabbinavar, MD, FACP, as chief medical officer (CMO).  Dr. Kabbinavar will oversee the clinical development program for the Company's investigational drug onvansertib and will report directly to Chief Executive Officer, Mark Erlander, PhD.

Key Points: 
  • Dr. Kabbinavar will oversee the clinical development program for the Company's investigational drug onvansertib and will report directly to Chief Executive Officer, Mark Erlander, PhD.
  • Dr. Kabbinavar joins Cardiff Oncology with more than 30 years of experience that bridges both the academic and biotech/pharmaceutical sectors.
  • "His experience guiding the development and registration of high-impact oncology drugs adds critical and relevant expertise to the Cardiff team.
  • In connection with Dr. Kabbinavar joining Cardiff Oncology, the Company's Board of Directors approved the grant of non-qualified stock options to purchase 425,000 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan.

James A. Reeves, Jr., MD, Clinical Research Leader, to Retire From Florida Cancer Specialists & Research Institute

Retrieved on: 
Monday, January 30, 2023
Oncology, FCS, Journal of Clinical Oncology, University, American Society of Pediatric Hematology/Oncology, Clinical research, Medical director, Knowledge, Internal medicine, Cancer, Medicine, Retirement, Hurricane Research Division, Drug development, Hospital, Medical Center of Louisiana at New Orleans, Patient, Clinical trial, Journal, Sandwell and West Birmingham Hospitals NHS Trust, Hematology, Blood, Research, Medical imaging, Medical device, Pharmaceutical industry, MD

FORT MYERS, Fla., Jan. 30, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) announces that James A. Reeves Jr, MD will retire from its Research Division, effective January 31, 2023.

Key Points: 
  • FORT MYERS, Fla., Jan. 30, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) announces that James A. Reeves Jr, MD will retire from its Research Division, effective January 31, 2023.
  • He joined the statewide practice in 1988 and served as Medical Director of the Clinical Research Program from 2017 until April 2021.
  • In his retirement, Dr. Reeves intends to stay connected to the practice and research by assisting with clinical trial matching efforts.
  • His work has been published frequently in such prestigious journals as Blood, Journal of Clinical Oncology, New England Journal of Medicine and Clinical Genitourary Cancer.

Phase 1 Clinical Data of Milademetan Published in Journal of Clinical Oncology

Retrieved on: 
Monday, January 23, 2023
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NEWARK, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Rain Oncology Inc. (NasdaqGS: RAIN), (“Rain”), a late-stage company developing precision oncology therapeutics with its lead product candidate, milademetan, an oral, small molecule inhibitor of the p53-MDM2 complex that reactivates p53, today announced the publication of a peer-reviewed article titled, “A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients with Advanced Liposarcoma, Solid Tumors or Lymphomas” in the Journal of Clinical Oncology. Phase 1 clinical data in the paper highlight the activity and tolerability using intermittent dosing of milademetan across a range of tumor types including dedifferentiated liposarcoma (DD LPS), which represented the largest proportion of patients enrolled in the study (n=53).

Key Points: 
  • Phase 1 clinical data in the paper highlight the activity and tolerability using intermittent dosing of milademetan across a range of tumor types including dedifferentiated liposarcoma (DD LPS), which represented the largest proportion of patients enrolled in the study (n=53).
  • “An intermittent dosing schedule (260 mg qd, 3/14 days) of our highly selective inhibitor of the p53-MDM2 complex, milademetan, resulted in favorable safety and clinical activity in the Phase 1 trial in DD LPS patients,” said Robert Doebele, MD, Ph.D., co-founder, president and chief scientific officer of Rain.
  • The preferred intermittent dosing schedule of milademetan (260 mg qd 3/14 days) mitigates dose-limiting hematologic adverse events while maintaining activity, leading to:
    Fewer dose reductions (21.1%; n=8) and dose interruptions (15.8%; n=6) compared with extended/continuous schedules (23.3%; n=16 and 34.8%; n=24, respectively).
  • Preliminary single-agent activity with milademetan in DD LPS prompted the ongoing, randomized Phase 3 MANTRA trial (NCT04979442), with topline data anticipated in the first quarter of 2023.

MimiVax Announces Positive Final Data from the Phase IIa Study of SurVaxM for Newly Diagnosed Glioblastoma Published Today in the Journal of Clinical Oncology

Retrieved on: 
Thursday, December 15, 2022
Journal of Clinical Oncology, Beth Israel Deaconess Medical Center, Science in newly industrialized countries, Phase, Recurrence, Dana–Farber Cancer Institute, Oncology, Overlook Medical Center, MD, Baptist Health, Immunotherapy, American Journal of Clinical Oncology, Fred Hutchinson Cancer Research Center, Doctor of Philosophy, Diagnosis, Cleveland Clinic, UCSF Medical Center, Progression-free survival, Patient, JCO, Roswell Park Comprehensive Cancer Center, Survivin, NYU Langone Health, Hospital, Survival rate, Baptist Health South Florida, Disease, Phases of clinical research, MOS, Cancer, Texas Oncology, Massachusetts General Hospital, Survival, Manuscript, Journal, Multimedia, IIA, GBM, MBA, Pharmaceutical industry, Medical imaging, Medical device, Glioblastoma

SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years.

Key Points: 
  • SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years.
  • MimiVax announces positive Phase 2A SurVaxM data in GBM, 2yr survival rate of 51%, published in JCO
    This multi-center, open label, single arm, phase IIa trial in adult patients with nGBM was approved by the institutional review boards at each of the participating hospitals [NCT02455557].
  • Of 63 patients enrolled, 60 (95.2%) remained progression-free 6 months after diagnosis to successfully reach the study primary endpoint.
  • "These promising results seen in the Phase IIa study compare favorably to the historical contemporary outcomes seen in glioblastoma.

Level One Evidence Proves Premenopausal Patients within the Ultra-Low Subset of Agendia’s MammaPrint Low Risk Result Can Safely Forgo Chemotherapy

Retrieved on: 
Tuesday, December 6, 2022
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Agendias MammaPrint is the only FDA-cleared test that can identify an Ultra-Low risk tumor as a separate risk level from the Low-risk group and therefore inform distinct treatment plans.

Key Points: 
  • Agendias MammaPrint is the only FDA-cleared test that can identify an Ultra-Low risk tumor as a separate risk level from the Low-risk group and therefore inform distinct treatment plans.
  • Without the level of precision MammaPrint offers, these tumors risk may be underestimated or overtreated.
  • While Agendias original MINDACT data found a small 3-4% chemotherapy benefit in premenopausal women with a MammaPrint Low risk result, according to a panel of breast cancer experts including Drs.
  • MammaPrint is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patients breast cancer recurrence risk.

Genialis Presents New Clinical Biomarker Findings at SITC, BioTechX

Retrieved on: 
Tuesday, November 8, 2022
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Also this week, Genialis CEO Rafael Rosengarten, Ph.D., will be at BiotechX (Basel) describing the unique approach and technological innovations that make ResponderID biomarkers successful.

Key Points: 
  • Also this week, Genialis CEO Rafael Rosengarten, Ph.D., will be at BiotechX (Basel) describing the unique approach and technological innovations that make ResponderID biomarkers successful.
  • Genialis also co-authored a paper in the Journal of Clinical Oncology describing OncXerna's navicixizumab ph1b trial, including retrospective analysis with the Xerna TME Panel.
  • Weve shared much of this progress with the scientific and clinical communities at numerous conferences this year, said Rafael Rosengarten, Ph.D., CEO of Genialis.
  • ResponderID, Genialis clinical biomarker discovery platform, defines, models, and validates actionable biomarkers and optimally positions novel drugs to accelerate translational research and clinical development.

Deciphera Pharmaceuticals, Inc. Announces Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 3, 2022
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Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.
  • Cash Position: As of September 30, 2022, cash, cash equivalents, and marketable securities were $371.6 million, compared to $393.1 million as of June 30, 2022.
  • Deciphera will host a conference call and webcast to discuss this announcement today, November 3, 2022, at 8:00 AM ET.
  • Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of Deciphera Pharmaceuticals, LLC.