Sunitinib

Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, February 26, 2024
HER2, PFS, AAAAI, KIT, Research, Completeness, TSS, ASCO, ASH, WT, Cash, Part, Safety, PEAK, AACR, Cogent, Conference, GIST, Society, PPR, Patient, The, PIPE, FGFR2, Clinical trial, Poster, G&A, Sunitinib, Initiate, IND, Brain, TKI, APEX, Cancer, American Academy, Pharmaceutical industry

WALTHAM, Mass. and BOULDER, Colo., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2023.

Key Points: 
  • and BOULDER, Colo., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2023.
  • SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).
  • Cash and Cash Equivalents: As of December 31, 2023, Cogent had cash, cash equivalents and marketable securities of $273.2 million.
  • During the quarter Cogent also completed and paid for bulk manufacturing campaigns of bezuclastinib to continue supporting the company’s clinical trials.

Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 6, 2024
Biotechnology, Pharmaceutical, Health, Oncology, OS, KIT, European, Investigational New Drug, Trial of the century, DNA, Research, Patient, IND, Autophagy, ASCO, GIST, Public expenditure, FDA, EMA, MAA, Part, Food, Society, TGCT, Gastrointestinal stromal tumor, European Medicines Agency, Sunitinib, Neoplasm, Cancer, INSIGHT, Tenosynovial giant cell tumor, NDA, Nature Medicine, Pharmaceutical industry

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 fourth quarter and year ended December 31, 2023 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 fourth quarter and year ended December 31, 2023 and provided a corporate update.
  • Expects to present updated results from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Expects to initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of chronic graft versus host disease (cGVHD) in the fourth quarter of 2024.
  • Cost of Sales: Cost of sales were $1.8 million in the fourth quarter of 2023, which includes $0.9 million in cost of product sales, compared to cost of product sales of $0.7 million for the fourth quarter of 2022.

Eight-Year Data for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Continue to Demonstrate Longest Survival Benefit vs. Sunitinib Reported in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Retrieved on: 
Monday, January 22, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bristol Myers Squibb, Death, Checkmate, Patient, Progression-free survival, OS, RCC, ASCO, Survival, Nivolumab, Ipilimumab, IRRC, Society, Risk, Immunotherapy, MD Anderson Cancer Center, Division, PFS, Abstract, Safety, Confidence interval, University, BMY, Sunitinib, IMDC, ITT

Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.

Key Points: 
  • Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.
  • DOR: Median DOR was 82.8 months for patients treated with Opdivo plus Yervoy compared to 19.8 months with sunitinib.
  • ORR: ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib (42% vs. 27%).
  • DOR: For patients treated with Opdivo plus Yervoy, median DOR was 76.2 months compared to 25.1 months with sunitinib.

Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma

Retrieved on: 
Monday, January 22, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Exelixis, Checkmate, Patient, Progression-free survival, OS, Partnership, RCC, ASCO, Survival, Society, Risk, Metastasis, PFS, Abstract, Safety, Liver, Confidence interval, GU, BMY, Sunitinib, IMDC, Pharmaceutical industry

Superior overall survival (OS) was also observed in patients treated with the combination.

Key Points: 
  • Superior overall survival (OS) was also observed in patients treated with the combination.
  • ORR (secondary endpoint): The combination regimen showed durable response improvements, doubling the ORR compared to sunitinib (55.7% vs. 27.7%, respectively).
  • ORR: In patients with intermediate-/ poor-risk, ORR was more than doubled at 52.6% with Opdivo and CABOMETYX vs. 23.0% with sunitinib.
  • In those with favorable risk profiles, the number of patients who achieved CR was doubled (16.2% vs. 8.3%) with the combination regimen.

Deciphera Pharmaceuticals Presents Long-Term Follow-Up Results from INTRIGUE Phase 3 Clinical Study in Second-Line GIST Patients at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Patient, Progression-free survival, KIT, Neoplasm, OS, Hypertension, ASCO, Fatigue, Society, Cancer, Myalgia, Survival rate, Public health, INSIGHT, AP, PFS, Safety, Diarrhea, GIST, Sunitinib, Nature Medicine, Preventive healthcare, Pharmaceutical industry

There were fewer patients with Grade 3/4 drug-related treatment emergent adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib (55.2%).

Key Points: 
  • There were fewer patients with Grade 3/4 drug-related treatment emergent adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib (55.2%).
  • Dose interruptions and reductions as well as treatment discontinuations due to TEAEs were lower with QINLOCK versus sunitinib.
  • Patients with mutations in KIT exon 11 and 17/18 had improved progression-free survival, objective response rate, and overall survival with QINLOCK versus sunitinib.
  • Based on the results of this prespecified exploratory objective in INTRIGUE, the Company is enrolling the INSIGHT pivotal Phase 3 clinical study of QINLOCK in second-line GIST patients with mutations in KIT exon 11 and 17/18 only.

Bristol Myers Squibb Data at ASCO GU 2024 Showcase Transformative Research in the Treatment of Genitourinary Cancers

Retrieved on: 
Wednesday, January 17, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bristol Myers Squibb, Checkmate, Patient, Research, Drug development, RCC, ASCO, Survival, Ipilimumab, Society, Cancer, Immunotherapy, Safety, BMY, LDD, Sunitinib, Pharmacokinetics, Pharmaceutical industry

Data from 14 company-sponsored studies, investigator-sponsored studies and collaborations will be presented at the meeting.

Key Points: 
  • Data from 14 company-sponsored studies, investigator-sponsored studies and collaborations will be presented at the meeting.
  • , executive vice president and chief medical officer, Drug Development, Bristol Myers Squibb.
  • “These results simultaneously showcase the ongoing success of Opdivo-based combinations in metastatic disease and our contributions to the future of cancer treatment and research.
  • These data represent the longest survival benefit vs. sunitinib reported in patients with previously untreated advanced or metastatic RCC.

Deciphera Pharmaceuticals Announces Nature Medicine Publication of Results from Exploratory ctDNA Analysis from INTRIGUE Phase 3 Study Demonstrating Substantial Clinical Benefit of QINLOCK® in 2L GIST Patients with Mutations in KIT Exon 11 and 17/18

Retrieved on: 
Friday, January 5, 2024
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Patient, Gastrointestinal stromal tumor, Survival, Risk, Neoplasm, INSIGHT, Progression-free survival, Disease, KIT, DNA, Cancer, Liquid biopsy, Exon, Death, Nature Medicine, Manuscript, Overalls, PFS, Sunitinib, AP, GIST, Pharmaceutical industry

“The results published in Nature Medicine provide compelling evidence that QINLOCK may provide progression-free and overall survival benefit to second-line (2L) GIST patients in whom a liquid biopsy reveals primary KIT exon 11 mutations plus secondary mutations restricted to KIT exons 17 and 18.

Key Points: 
  • “The results published in Nature Medicine provide compelling evidence that QINLOCK may provide progression-free and overall survival benefit to second-line (2L) GIST patients in whom a liquid biopsy reveals primary KIT exon 11 mutations plus secondary mutations restricted to KIT exons 17 and 18.
  • “Our ongoing INSIGHT pivotal Phase 3 study is designed to confirm the exceptional efficacy we observed in this exploratory analysis from INTRIGUE.
  • A prespecified exploratory objective in INTRIGUE was to evaluate anti-tumor efficacy of QINLOCK according to baseline KIT primary and secondary mutation status.
  • In patients with a detectable KIT exon 11 primary mutation (n=157), 52 patients also had mutations in KIT exon 17/18 only and 41 had mutations in KIT exon 13/14 only.

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Marketing, Hypothyroidism, INN, Woman, Progression-free survival, Nausea, Syndrome, Heart, Cancer, Inflammation, Skull, Proteinuria, Anatomy, Cell division, IIA, Diarrhea, Fatigue, ATC, Capsule, Bleeding, Pancreas, RET, VEGF, FGFR, Cerebral edema, Neoplasm, Stroke, Enzyme, Liver failure, Safety, Kidney cancer, Arthralgia, Heart failure, Patient, Urine, Medical Subject Headings, Stomatitis, Immune system, Everolimus, International, Encephalopathy, Language, Somatic symptom disorder, Blood, Mouth, Catherine Disher, Select, Medicine, Vomiting, Pembrolizumab, Cholesterol, PDGF, Kidney failure, Weight loss, Headache, KIT, Brain, Acral lentiginous melanoma, Swelling, Hypoesthesia, Splenic infarction, Confusion, European Medicines Agency, RCC, Kidney, Growth, Sunitinib, Hypercholesterolemia, Rash, Medical device

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
Patient, Research, MAS, IND, American Society of Clinical Oncology, APEX, FGFR2, PEAK, G&A, Novel, Safety, Conference, D, PGIC, Society, WT, Cogent, Pharmacokinetics, ASH, Clinical trial, Efficacy, Sunitinib, ORR, GIST, Part, Drug discovery, ASCO, American Society of Hematology, ENA, Acceleration, Pharmaceutical industry, Nursing, Video game, Q3

WALTHAM, Mass. and BOULDER, Colo., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • and BOULDER, Colo., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2023.
  • Cogent will host an investor webcast to review the results on Monday, December 11, 2023 at 8:00 a.m.
  • G&A Expenses: General and administrative expenses were $9.5 million for the third quarter of 2023 as compared to $6.9 million for the third quarter of 2022.
  • G&A expenses include non-cash stock compensation expense of $4.8 million for the third quarter of 2023 compared to $2.6 million for the third quarter of 2022.

LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, May 26, 2023
MSD, Senior, Hepatocellular carcinoma, Pharming, Sunitinib, Survival, Head, DO, Cancer, Patient, Stomatitis, Risk, Merck, Fatigue, Texas Oncology, Diarrhea, Pembrolizumab, FACP, Research, Lung cancer, Merck & Co., Hypertension, LEAP, HIV disease progression rates, Esophageal cancer, Abstract, Death, Apoptosis, Lenvatinib, Overalls, PFS, Eisai, CR, Stomach, ORR, Acral lentiginous melanoma, Arm, Progression-free survival, RCC, CI, OS, Drug, Trae tha Truth, Hypothyroidism, ASCO, Central Time Zone, American Society of Clinical Oncology, Cancer Treatment Centers of America, Physician, Annual general meeting, Nausea, Society, Pharmaceutical industry, EU

After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for LENVIMA plus KEYTRUDA versus 69.6% and 60.2% for sunitinib, respectively.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received LENVIMA plus KEYTRUDA versus 60.3% of patients who received sunitinib.
  • These findings reinforce the important role of LENVIMA plus KEYTRUDA as a first-line standard of care treatment option for patients with advanced renal cell carcinoma."