Cholangiocarcinoma

Agios Submits Supplemental New Drug Application to FDA for TIBSOVO® (ivosidenib tablets) for Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma

Monday, March 1, 2021 - 12:00pm

Agios has requested priority review for the application, which, if granted, could result in a six-month review process.

Key Points: 
  • Agios has requested priority review for the application, which, if granted, could result in a six-month review process.
  • The sNDA submission is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.
  • There are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available in the advanced setting.
  • Patients treated with TIBSOVOhave experienced symptoms of differentiation syndrome, which can be fatal if not treated.

Eisai: MHLW Grants Orphan Drug Designation in Japan to Novel FGF Receptor Selective Tyrosine Kinase Inhibitor E7090

Monday, February 22, 2021 - 6:40am

In Japan, a Phase I clinical trial of E7090 was conducted, and E7090 has been designated as the target drug for the SAKIGAKE Designation System of the MHLW for the treatment of unresectable biliary tract cancer.

Key Points: 
  • In Japan, a Phase I clinical trial of E7090 was conducted, and E7090 has been designated as the target drug for the SAKIGAKE Designation System of the MHLW for the treatment of unresectable biliary tract cancer.
  • Discovered in-house by Eisai's Tsukuba Research Laboratories, E7090 is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2 and FGFR3.
  • et al., "Biliary tract cancer registry in Japan from 2008 to 2013", J Hepatobiliary Pancreat Sci., 2016, 23, 149-157.
  • (6) Arai Y. et al., "Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma", Hepatology, 2014, 59, 1427-1434.

7MM Biliary Tract Cancers Market to 2030 - Insight, Epidemiology and Forecasts - ResearchAndMarkets.com

Thursday, February 11, 2021 - 4:03pm

The "Biliary Tract Cancers (BTCs) - Market Insight, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Biliary Tract Cancers (BTCs) - Market Insight, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The biliary tract cancer market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted biliary tract cancer market Size from 2017 to 2030, segmented by seven major markets.
  • The disease epidemiology covered in the report provides historical and forecasted Biliary Tract Cancer epidemiology segmented as the total incident cases of biliary tract cancer, age-specific cases of biliary tract cancer, stage-specific cases of biliary tract cancer and mutation specific cases of biliary tract cancer.
  • To understand the future market competition in the biliary tract cancer market and Insightful review of the key market drivers and barriers.

InnoCare Announces First Subject Dosed in Clinical Trial of ICP-192 in the U.S.

Thursday, February 4, 2021 - 1:47am

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States.

Key Points: 
  • InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States.
  • ICP-192 is a highly selective small-molecule pan-FGFR inhibitor for the treatment of various solid tumors with FGFR aberrations.
  • Currently it is in Phase I/II clinical studies in China and the United States.
  • The Phase II trial in China is a multi-center, open-label clinical trial designed to evaluate the safety and efficacy of ICP-192 in patients with advanced cholangiocarcinoma and urothelial cancer that have FGFR aberrations.

Sirnaomics to Present at Medical Dermatology Summit

Tuesday, February 2, 2021 - 4:33pm

STP705 has also received three Orphan Drug Designations from the US FDA for treatment of cholangiocarcinoma, primary sclerosing cholangitis and Hepatocellular Carcinoma.

Key Points: 
  • STP705 has also received three Orphan Drug Designations from the US FDA for treatment of cholangiocarcinoma, primary sclerosing cholangitis and Hepatocellular Carcinoma.
  • Based on the results of the STP705 Phase 2a trial, Sirnaomics intends to initiate a Phase 2b trial of STP705 in patients with isSCC, Bowen's disease.
  • The company's mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need.
  • Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline.

Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement

Friday, January 29, 2021 - 6:36pm

The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Key Points: 
  • The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.
  • If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement and would be commercialized under the brand name Pemazyre.
  • Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor1,2.
  • FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

Agios Presents Final Data from Phase 3 ClarIDHy Study of TIBSOVO® (ivosidenib tablets) in Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma

Sunday, January 17, 2021 - 3:00pm

The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.

Key Points: 
  • The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.
  • As of the May 31, 2020 data cutoff, 187 patients were randomized, with 126 patients in the TIBSOVO arm and 61 patients in the placebo arm.
  • Forty-three patients randomized to placebo (70.5%) crossed over to open-label TIBSOVO upon radiographic disease progression and unblinding.
  • Agios plans to submit a supplemental new drug application for TIBSOVO in previously treated IDH1-mutant cholangiocarcinoma in the first quarter of 2021.

Zanidatamab Clinical Data Selected for Oral Presentation at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium

Thursday, December 10, 2020 - 1:30pm

Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the selection of three abstracts for presentation at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, taking place virtually on January 15 17, 2021.

Key Points: 
  • Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the selection of three abstracts for presentation at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, taking place virtually on January 15 17, 2021.
  • The presentations highlight updated clinical data for the HER2targeted bispecific antibody, zanidatamab, in HER2expressing gastroesophageal adenocarcinoma (both as monotherapy and in combination with chemotherapy) and in HER2-expressing/amplified biliary tract cancer (as monotherapy).
  • Title: Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): Results from a phase I study.
  • Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.

Intrahepatic Cholangiocarcinoma Industry to 2030 - Insights, Epidemiology, and Market Forecast - ResearchAndMarkets.com

Friday, December 4, 2020 - 1:12pm

The "Intrahepatic Cholangiocarcinoma (ICCA) - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Intrahepatic Cholangiocarcinoma (ICCA) - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The ICCA market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM ICCA market size from 2017 to 2030.
  • The Report also covers current ICCA treatment practice/algorithm, market drivers, market barriers, unmet medical needs, SWOT analysis to curate the best of the opportunities, and assesses the underlying potential of the market.
  • The market size of Intrahepatic Cholangiocarcinoma (ICCA) in the 7MM was USD 99.78 million in 2017.

LianBio Announces Clearance to Initiate in China the Phase 2a Trial of Infigratinib in Patients with Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma with FGFR2 Gene Amplification

Tuesday, December 1, 2020 - 12:00pm

The Phase 2a trial is a multicenter, single-arm study designed to explore and evaluate the pharmacokinetic profile, efficacy and safety of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification.

Key Points: 
  • The Phase 2a trial is a multicenter, single-arm study designed to explore and evaluate the pharmacokinetic profile, efficacy and safety of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification.
  • Infigratinib is also currently under Phase 3 global development by LianBio and BridgeBio for patients with FGFR2 fusion positive cholangiocarcinoma.
  • Gastric cancer is the third most common cancer in China, causing approximately 300,000 deaths every year.
  • This clearance by the China NMPA to conduct the Phase 2a trial of infigratinib in gastric cancer will enable LianBio to work towards addressing the significant unmet medical need for this growing patient population.