Sunitinib

Deciphera Pharmaceuticals Completes Target Enrollment in the INTRIGUE Phase 3 Clinical Study of QINLOCK® (Ripretinib) in Patients with Second-Line Gastrointestinal Stromal Tumor

Retrieved on: 
måndag, november 30, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Health sciences, Clinical medicine, Cancer treatments, Pyridines, Orphan drugs, Indoles, Pyrroles, Sunitinib, Ripretinib, Gastrointestinal stromal tumor, Imatinib, QINLOCK (ripretinib), GIST, Deciphera Pharmaceuticals

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST).

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST).
  • The INTRIGUE Phase 3 clinical study is a randomized, global, multicenter, open-label study to evaluate the efficacy and safety of QINLOCK compared to sunitinib in patients with GIST previously treated with imatinib.
  • This study was designed to support regulatory approvals in second-line GIST patients in the United States, Europe, and other major markets.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera, Deciphera Pharmaceuticals, and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

Cogent Biosciences Announces Final Results from PLX9486 Phase 1/2 Study in Advanced GIST Patients at CTOS 2020

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onsdag, november 18, 2020
Pyrroles, Indoles, Sunitinib, Clinical medicine, Gastrointestinal stromal tumor, Cancer, Gist, Kit, Medicine, Antineoplastic drugs, Ripretinib, Evofosfamide

CAMBRIDGE, Mass., Nov. 18, 2020 /PRNewswire/ -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the final results from its PLX9486 + sunitinib Phase 1/2 study in patients with advanced gastrointestinal stromal tumors (GIST).

Key Points: 
  • CAMBRIDGE, Mass., Nov. 18, 2020 /PRNewswire/ -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the final results from its PLX9486 + sunitinib Phase 1/2 study in patients with advanced gastrointestinal stromal tumors (GIST).
  • "We are pleased to share final results from our Phase 1/2 trial of PLX9486 + sunitinib and are excited to advance this combination into a Phase 3 GIST trial in the second half of 2021," said Andrew Robbins, President and CEO of Cogent Biosciences.
  • Title:The potent and selective kit inhibitor PLX9486 dosed in combination with sunitinib demonstrates promising progression free survival (PFS) in patients with advanced gastrointestinal stromal tumor (GIST): final results of a phase 1/2 study.
  • Out of the 18 patients with advanced GIST enrolled in the trial, all patients had received prior treatment, including 67% of patients with at least three prior lines of therapy.

LENVIMA Plus KEYTRUDA Demonstrated Statistically Significant Improvement in Progression-Free Survival, Overall Survival and Objective Response Rate Versus Sunitinib as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
onsdag, november 11, 2020
Cancer treatments, Medicine, Clinical medicine, Antineoplastic drugs, Clinical trials, Medical statistics, Medical terminology, Indoles, Sunitinib, Clinical endpoint, Progression-free survival, Survival rate

LENVIMA plus KEYTRUDA met the trial's primary endpoint of Progression-Free Survival (PFS) and its key secondary endpoints of Overall Survival (OS) and Objective Response Rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population.

Key Points: 
  • LENVIMA plus KEYTRUDA met the trial's primary endpoint of Progression-Free Survival (PFS) and its key secondary endpoints of Overall Survival (OS) and Objective Response Rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population.
  • The ITT population included patients across all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor).
  • The safety profiles of both LENVIMA plus KEYTRUDA and LENVIMA plus everolimus were consistent with previously reported studies.
  • "The results from CLEAR (Study 307)/KEYNOTE-581 support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC.

Xencor Presents Updated Data From the DUET-2 Phase 1 Study of XmAb20717, PD-1 x CTLA-4 Bispecific Antibody, at the SITC Annual Meeting

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måndag, november 9, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Histopathology, Prostate cancer, Cancer, Organ systems, Andrology, Bicalutamide, Sunitinib, Prostvac, XmAb®20717, Xencor, Inc.

Though data are early, we are especially encouraged by initial activity in patients with metastatic castration-resistant prostate cancer.

Key Points: 
  • Though data are early, we are especially encouraged by initial activity in patients with metastatic castration-resistant prostate cancer.
  • We are also planning additional cohorts in selected populations within DUET-2, based on clinical activity and unmet medical need.
  • Data are also still maturing in cohorts of patients with renal cell carcinoma, and those with cancers without approved checkpoint therapies, including prostate cancer.
  • In the studys escalation phase, 34 patients have been treated with doses escalating from 0.15 to 10 mg/kg.

ESMO 2020: Cabometyx® (cabozantinib) in Combination With Opdivo® (nivolumab) Demonstrates Significant Survival Benefits in Patients With Advanced Renal Cell Carcinoma in Pivotal Phase III CheckMate -9ER Trial

Retrieved on: 
lördag, september 19, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Cancer treatments, Antineoplastic drugs, Clinical medicine, RTT, Indoles, Pyrroles, Sunitinib, Breakthrough therapy, Renal cell carcinoma, Nivolumab, Protein kinase inhibitor

Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months.

Key Points: 
  • Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months.
  • All these key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 subgroups.
  • The CheckMate -9ER data demonstrate meaningful efficacy benefits with nivolumab plus cabozantinib, which significantly improved overall survival and doubled progression-free survival and objective response rate with consistent effects observed across pre-specified subgroups.
  • Cabometyx in combination with Opdivo was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in previously untreated advanced RCC.

Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Retrieved on: 
torsdag, september 17, 2020
Oncology, Health, Stem cells, Clinical trials, Pharmaceutical, Biotechnology, Cancer treatments, Drugs, Bristol-Myers Squibb, Clinical medicine, Antineoplastic drugs, Breakthrough therapy, RTT, Ipilimumab, Sunitinib, Nivolumab, Renal cell carcinoma

CR: As previously reported, 11% of patients who received Opdivo plus Yervoy achieved a CR, compared to 3% with sunitinib.

Key Points: 
  • CR: As previously reported, 11% of patients who received Opdivo plus Yervoy achieved a CR, compared to 3% with sunitinib.
  • CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
  • OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).
  • In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients.

Deciphera Announces Health Canada’s Authorization of QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor

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måndag, juni 22, 2020
Oncology, Health, FDA, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Heterocyclic compounds, Cancer treatments, Pyridines, Imatinib, Piperazines, RTT, Protein kinase inhibitor, Gastrointestinal stromal tumor, Mastocytosis, Sunitinib, the INVICTUS Phase 3 Study, GIST, Deciphera Pharmaceuticals

Health Canadas authorization was based on efficacy results from the pivotal Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK.

Key Points: 
  • Health Canadas authorization was based on efficacy results from the pivotal Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK.
  • Deciphera Pharmaceuticals is developing QINLOCK for the treatment of KIT and/or PDGFR-driven cancers, including GIST, systemic mastocytosis, or SM, and other cancers.
  • QINLOCK (ripretinib) is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
  • Deciphera, Deciphera Pharmaceuticals, QINLOCK, the Deciphera logo and the QINLOCK logo are trademarks of Deciphera Pharmaceuticals, LLC.

FDA Grants Full Approval of Deciphera Pharmaceuticals’ QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor

Retrieved on: 
fredag, maj 15, 2020
Biotechnology, Pharmaceutical, Oncology, Health, FDA, Fitness & Nutrition, Clinical trials, Other Health, Chemical compounds, Pyridines, Cancer treatments, Organic compounds, Clinical medicine, Protein kinase inhibitor, Imatinib, Gastrointestinal stromal tumor, Nilotinib, Sunitinib, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Fitness & Nutrition, Clinical trials, Other Health, Chemical compounds, Pyridines, Cancer treatments, Organic compounds, Clinical medicine, Protein kinase inhibitor, Imatinib, Gastrointestinal stromal tumor, Nilotinib, Sunitinib, the INVICTUS Phase 3 Study, QINLOCK (ripretinib), GIST, Deciphera Pharmaceuticals

Deciphera Pharmaceuticals plans to make QINLOCK commercially available in the U.S. next week.

Key Points: 
  • Deciphera Pharmaceuticals plans to make QINLOCK commercially available in the U.S. next week.
  • As part of that commitment, Deciphera has established Deciphera AccessPoint, a patient support program that provides reimbursement and financial assistance programs for eligible patients.
  • QINLOCK (ripretinib) is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
  • QINLOCK, the QINLOCK logo, Deciphera, Deciphera Pharmaceuticals, and the Deciphera logo are trademarks of Deciphera Pharmaceuticals, LLC.

Chi-Med Announces Surufatinib Granted U.S. FDA Fast Track Designations for the Treatment of Both Pancreatic and Non-Pancreatic Neuroendocrine Tumors

Retrieved on: 
fredag, april 17, 2020
Medicine, Cancer, Clinical medicine, Pancreatic cancer, Antineoplastic drugs, Cancer treatments, Neuroendocrine tumor, Neuroendocrinology, Sunitinib, Endocrine oncology, Pancreatic neuroendocrine tumor, Fast track

The FDA Fast Track Designation is one of several approaches utilized by the U.S. FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs.

Key Points: 
  • The FDA Fast Track Designation is one of several approaches utilized by the U.S. FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs.
  • Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.
  • In addition to the aforementioned grants of Fast Track Designation in pancreatic and non-pancreatic NET in the U.S., surufatinib was granted Orphan Drug Designation for pancreatic NET in November 2019.
  • Approved targeted therapies include Sutent and Afinitor for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.

2020 Pipeline Insight on Advanced Renal Cell Carcinoma (RCC) - ResearchAndMarkets.com

Retrieved on: 
måndag, februari 17, 2020
Health, Oncology, Kidney cancer, Medicine, Clinical medicine, Chemical compounds, Renal cell carcinoma, Kidney, Neprilysin, Sunitinib, Papillary duct

The "Advanced Renal Cell Carcinoma (RCC) - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Advanced Renal Cell Carcinoma (RCC) - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • A detailed picture of the advanced renal cell carcinoma (RCC) pipeline landscape is provided, which includes the disease overview and advanced renal cell carcinoma (RCC) treatment guidelines.
  • The assessment part of the report embraces in-depth advanced renal cell carcinoma (RCC) commercial assessment and clinical assessment of the advanced renal cell carcinoma (RCC) pipeline products from the pre-clinical developmental phase to the marketed phase.
  • How many advanced renal cell carcinoma (RCC) emerging therapies are in early-stage, mid-stage, and late stage of development for the treatment of advanced renal cell carcinoma (RCC)?