Independent Review Committee

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

RemeGen Presents Oral Presentation on Evaluation of Its Proprietary Disitamab Vedotin (RC48) for Cervical Cancer at ESGO 2024

Retrieved on: 
Monday, March 11, 2024
HER2, Cervical cancer, Congress, ECOG, Immunotherapy, Progression-free survival, DCR, Patient, Research, IIB, Șaeș, Safety, Dor, Carcinoma, ESGO, Adenocarcinoma, PFS, FIGO, ADC, Independent Review Committee, Pharmaceutical industry

The cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+.

Key Points: 
  • The cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+.
  • As of October 31, 2023, 25 patients with cervical cancer were enrolled with a median age of 56 years (range: 35-66).
  • In conclusion, RC48 demonstrates a manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it to be a promising new treatment for HER2-expressed cervical cancer.
  • I am delighted to share an oral presentation on the evaluation of our proprietary ADC Disitamab Vedotin at ESGO 2024.

NCM Asset Management Ltd. Announces Proposed Fund Merger and Securityholder Meeting

Retrieved on: 
Friday, February 16, 2024
NCM, Independent Review Committee, Divergence (computer science), IRC, Financial adviser

Calgary, Alberta--(Newsfile Corp. - February 16, 2024) - NCM Asset Management Ltd. ("NCM"), the manager of a strategically focused group of public mutual funds, alternative investment funds, and related products and services, announced plans to merge NCM Balanced Income Fund (the "Terminating Fund") into NCM Growth & Income Portfolio (the "Continuing Fund"), subject to securityholder and regulatory approval.

Key Points: 
  • Calgary, Alberta--(Newsfile Corp. - February 16, 2024) - NCM Asset Management Ltd. ("NCM"), the manager of a strategically focused group of public mutual funds, alternative investment funds, and related products and services, announced plans to merge NCM Balanced Income Fund (the "Terminating Fund") into NCM Growth & Income Portfolio (the "Continuing Fund"), subject to securityholder and regulatory approval.
  • NCM announced that the special securityholder meeting (the "Meeting") of the Terminating Fund called to consider the proposed merger has been scheduled on or about May 7, 2024.
  • Pursuant to the proposed merger, the Continuing Fund will acquire all or substantially all of the net assets of the Terminating Fund and securityholders of the Terminating Fund will exchange their units of the Terminating Fund for the corresponding series of units of the Continuing Fund such that securityholders of the Terminating Fund will become securityholders of the Continuing Fund.
  • As soon as reasonably possible following completion of the proposed merger, the Terminating Fund will be terminated.

Merck KGaA, Darmstadt, Germany Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib

Retrieved on: 
Monday, December 4, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Medicine, Independent Review Committee, Safety, Therapy, RECIST, Disease, Stiffness, Patient, TGCT, Joint, Merck, Tenosynovial giant cell tumor, Partnership, Pain, Swelling, Health care, Merck Group, Pharmaceutical industry, Hong Kong

The agreement grants Merck KGaA, Darmstadt, Germany a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.

Key Points: 
  • The agreement grants Merck KGaA, Darmstadt, Germany a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.
  • In addition, Merck KGaA, Darmstadt, Germany has the option to co-develop pimicotinib in additional indications under certain conditions.
  • Merck KGaA, Darmstadt, Germany will provide Abbisko with an upfront payment of $70 million and upon exercising the option, will provide Abbisko an option fee.
  • Abbisko will receive additional payments for the achievement of certain regulatory and commercial milestones, as well as double-digit tiered royalties on net sales by Merck KGaA, Darmstadt, Germany.

Merck Strengthens Oncology Portfolio Through Commercialization Agreement With Abbisko for Phase III Asset, Pimicotinib

Retrieved on: 
Monday, December 4, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Medicine, Independent Review Committee, Safety, Therapy, RECIST, Disease, Stiffness, Patient, TGCT, Science, Joint, Tenosynovial giant cell tumor, Partnership, Pain, Swelling, Health care, Pharmaceutical industry, Merck, Hong Kong

The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.

Key Points: 
  • The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.
  • The ongoing randomized, double-blind, placebo-controlled Phase III MANEUVER trial is evaluating the efficacy and safety of pimicotinib 50 mg QD in patients with unresectable TGCT.
  • Merck will provide Abbisko with an upfront payment of $70 million and upon exercising the option, will provide Abbisko an option fee.
  • Abbisko will receive additional payments for the achievement of certain regulatory and commercial milestones as well as double-digit tiered royalties on net sales by Merck.

87.5% ORR | Abbisko presented two clinical updates of Pimicotinib at the 2023 CTOS Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
PD, US, BTD, TGCT, Priority, Human, European Medicines Agency, IDMC, Male, Liver injury, Hip, BIRC, Ankle, PRO, Pain, IRC, Completeness, Part Two, Response evaluation criteria in solid tumors, QD, 1.1, MRI, Itch, AST, US FDA, CSF1, Motion, Rash, Neoplasm, Independent Review Committee, PK, ORR, Part, Safety, Therapy, ALT, Patient, LDH, ASCO, PDGFR, Contraindication, Nilotinib, III, DOR, Imatinib, Breakthrough therapy, Clinical trial, Hepatotoxicity, Knee, FDA, Dyslipidemia, CPK, RES, SD, RECIST, Pharmaceutical industry, Nursing

SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.

Key Points: 
  • SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.
  • The two clinical updates include reporting the design of the pivotal global multi-center phase III clinical trial and the further update of the phase Ib clinical trial of pimicotinib.
  • In 2023, the U.S. FDA conferred Breakthrough Therapy Designation and the European Medicines Agency granted Priority Medicine Designation upon Pimicotinib treatment of TGCT.
  • Here, we report the phase 1b safety and efficacy results of Pimicotinib in TGCT patients over a 1-year follow-up.

Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

Retrieved on: 
Monday, September 11, 2023
IRC, Hypophosphatemia, Progression-free survival, Xeroderma, Human, Arm, DOR, New Drug Application, NDA, LDH, Brain, CPK, CSR, PFS, Fatigue, Independent Review Committee, Patient, Anemia, Neoplasm, Ageing, FDA, AST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Food, Safety, Clinical study report, Pharmaceutical industry, Medical imaging, Road

BRISBANE, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the recently completed submission of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The Company anticipates the FDA will file the rolling NDA by mid-November 2023.

Key Points: 
  • For the majority of patients in the relapsed setting, there is no standard of care and no approved therapies.
  • An updated Clinical Study Report (CSR) was submitted to the FDA with an additional six months of safety and efficacy data through June 5, 2023.
  • The NDA submission also includes an exploratory analysis of ORR by Response Assessment for Neuro-Oncology Low-Grade Glioma (RANO-LGG).
  • Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2026.

Study Result of Orelabrutinib in Patients with r/r MZL Published by American Journal of Hematology

Retrieved on: 
Wednesday, September 13, 2023
Biotechnology, Pharmaceutical, Health, Lymphoma, IRC, Independent Review Committee, Journal, Progression-free survival, Hematology, DOR, Non-Hodgkin lymphoma, NHL, Neoplasm, American Journal of Hematology, BTK, PFS, Incidence, American Journal, Spleen, Patient, Lymph, Mantle cell lymphoma, SCIE, MCL, SCI, Marginal zone B-cell lymphoma, ORR, Safety, Pharmaceutical industry, Medical device

American Journal of Hematology recently published the study result of BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib in patients with relapsed or refractory (r/r) Marginal Zone Lymphoma (MZL), which investigated the efficacy and safety of orelabrutinib in r/r MZL.

Key Points: 
  • American Journal of Hematology recently published the study result of BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib in patients with relapsed or refractory (r/r) Marginal Zone Lymphoma (MZL), which investigated the efficacy and safety of orelabrutinib in r/r MZL.
  • The journal concluded that orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in patients with relapsed or refractory MZL.
  • The journal concluded that orelabrutinib produced a robust response and was well tolerated in r/r MZL patients.
  • The American Journal of Hematology is an academic journal focusing on hematology, which was founded in 1976 and published monthly by WILEY publisher.

HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer

Retrieved on: 
Tuesday, August 29, 2023
Adenocarcinoma, Independent Review Committee, AE, RECIST, Breakthrough therapy, PFS, Incidence, HKEX, Patient, GEJ, National Medical Products Administration, MET, Stomach, Safety, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 28, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies.
  • The study of savolitinib is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer or GEJ adenocarcinoma patients with MET amplification.
  • Primary endpoint is objective response rate (“ORR”) evaluated by the Independent Review Committee (“IRC”) (RECIST 1.1).
  • Secondary endpoints include progression free survival (PFS) and incidence of various adverse events (AE), among others.

U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma

Retrieved on: 
Thursday, August 10, 2023
Lymphocyte, Safety, Rash, Effectiveness, Janssen Pharmaceuticals, Patient, Fatigue, Disease, Tissue, REMS, University, Neutrophil, Diarrhea, GPRC5D, Xeroderma, Multiple myeloma, Hepatotoxicity, Bone marrow, Toxicity, Research, Ageusia, Independent Review Committee, Cytokine release syndrome, FDA, Headache, Skin, DSM-IV codes, Nail, CD3, CRS, Hypotension, Epithelium, Confidence interval, CR, Weight loss, Johnson & Johnson, Fever, ORR, Dysphagia, Mitigation, Xerostomia, SC, CI, B-cell maturation antigen, Clinical trial, Medicine, Physician, Upper respiratory tract infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, BCMA, Vaccine, Pharmaceutical industry, HORSHAM, Cytopenia, Bispecific monoclonal antibody, Dysgeusia, Infection

HORSHAM, Pa., Aug. 10, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TALVEY™ (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.1 This indication is approved under accelerated approval based on response rate and durability of response.1 Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s).1 

Key Points: 
  • * "Patients at this stage of disease have a poor prognosis.
  • Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer."
  • "Our team of scientists never settles in their determination to discover and develop effective therapies.
  • With the discovery of this new antigen, we continue to strive for research breakthroughs while remaining focused on delivering curative regimens in our commitment to eliminate cancer."