Ripretinib

Gastrointestinal Stromal Tumor (GIST) Market Spotlight Report 2021: 10-year Disease Incidence and Prevalence Forecasts, Probability of Success, Licensing and Asset Acquisition Deals, Revenue Forecasts - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 27, 2022

The "Market Spotlight: Gastrointestinal Stromal Tumor (GIST)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Spotlight: Gastrointestinal Stromal Tumor (GIST)" report has been added to ResearchAndMarkets.com's offering.
  • This Market Spotlight report covers the Gastrointestinal Stromal Tumor (GIST) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, regulatory events, probability of success, a 10-year disease incidence forecast, and drug-specific revenue forecasts.
  • The publisher estimates that in 2019, there were 100,200 incident cases of gastrointestinal stromal tumor (GIST) worldwide, and expects that number to increase to 109,000 incident cases by 2028.
  • Novartis leads industry sponsors with by far the highest overall number of clinical trials for GIST.

Deciphera Pharmaceuticals Announces Top-Line Results from the INTRIGUE Phase 3 Clinical Study

Retrieved on: 
Friday, November 5, 2021

The full results from the INTRIGUE Phase 3 clinical study are expected to be presented at an upcoming medical meeting, said Steve Hoerter, President and Chief Executive Officer of Deciphera.

Key Points: 
  • The full results from the INTRIGUE Phase 3 clinical study are expected to be presented at an upcoming medical meeting, said Steve Hoerter, President and Chief Executive Officer of Deciphera.
  • 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.
  • 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.
  • Deciphera Press Release: Deciphera Announces Approval of QINLOCK in Switzerland for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] October 12, 2021.

China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)

Retrieved on: 
Wednesday, March 31, 2021

NMPAs approval of QINLOCK establishes a new standard of care for treating patients with fourth-line GIST in China.

Key Points: 
  • NMPAs approval of QINLOCK establishes a new standard of care for treating patients with fourth-line GIST in China.
  • QINLOCK may potentially alter the treatment landscape for patients in China with GIST.
  • In March 2021, the NMPA approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

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: 
Monday, November 30, 2020

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

Retrieved on: 
Wednesday, November 18, 2020

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.

New Drug for Gastrointestinal Stromal Tumours (GIST) to be Launched in Australia, New Zealand and South East Asia Following Distribution Agreement

Retrieved on: 
Thursday, November 5, 2020

"QINLOCK represents another step forward to improve outcomes for patients who are affected by this rare cancer," Professor Zalcberg said.

Key Points: 
  • "QINLOCK represents another step forward to improve outcomes for patients who are affected by this rare cancer," Professor Zalcberg said.
  • "This is an area of high unmet need because of the poor prognosis of patients whose tumours continue to grow on prior treatment.
  • Deciphera Pharmaceuticalshas an exclusive distribution agreement with Specialised Therapeutics Asia (STA) for the commercialization of QINLOCK in Australia, New Zealand, Singapore, Malaysia and Brunei.
  • Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial.

Deciphera Pharmaceuticals Announces Submission of New Drug Application to U.S. FDA for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors

Retrieved on: 
Monday, December 16, 2019

The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review, or RTOR, pilot program.

Key Points: 
  • The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review, or RTOR, pilot program.
  • In October 2019, FDA granted Breakthrough Therapy Designation (BTD) for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
  • The NDA submission is supported by positive data from the Companys INVICTUS pivotal Phase 3 study of ripretinib in advanced GIST.
  • Ripretinib has also been granted Orphan Drug Designation for the treatment of GIST by the U.S. FDA and European Medicines Agency (EMA).

Deciphera Pharmaceuticals, Inc. to Present Data from DCC-3014 and Ripretinib Programs at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting

Retrieved on: 
Wednesday, November 13, 2019

Results from these programs will be presented at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting being held November 13-16 in Tokyo, Japan.

Key Points: 
  • Results from these programs will be presented at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting being held November 13-16 in Tokyo, Japan.
  • We are excited to share preliminary data from the initial TGCT patients enrolled in the ongoing Phase 1 study of DCC-3014.
  • Safety, pharmacokinetic, and pharmacodynamic data were analyzed as of September 10, 2019, with additional anti-tumor activity data reported as of November 8, 2019.
  • All three patients with diffuse-type TGCT treated as of the data analyses dates showed preliminary anti-tumor activity.

Deciphera Pharmaceuticals Presents Updated Data from Ripretinib and DCC-3014 Programs at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Tuesday, October 29, 2019

Ripretinib was generally well tolerated and the updated adverse events were consistent with previously presented Phase 1 data in patients with GIST.

Key Points: 
  • Ripretinib was generally well tolerated and the updated adverse events were consistent with previously presented Phase 1 data in patients with GIST.
  • As of the data cut-off date of September 10, 2019, increasing doses of DCC-3014 were assessed in seven dose cohorts across 36 patients with advanced solid tumor tumors.
  • The dose escalation evaluation is ongoing to determine a recommended phase 2 dose for advanced solid tumors and diffuse-type TGCT.
  • Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.

Deciphera Pharmaceuticals to Present Data Updates From Portfolio of Kinase Switch Control Inhibitors in Four Poster Sessions at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Wednesday, October 16, 2019

Ripretinib also inhibits primary PDGFR mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

Key Points: 
  • Ripretinib also inhibits primary PDGFR mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST.
  • Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.
  • DCC-3014 was designed using the Companys proprietary switch control kinase inhibitor platform to selectively bind to the CSF1R switch pocket.
  • DCC-3116 is a potential first-in-class small molecule designed to inhibit cancer autophagy, a key tumor survival mechanism, by inhibiting the ULK kinase.