Tyrosine kinase inhibitors

European Hematology Association - ALPINE Study Reveals Superior Safety and Efficacy of Zanubrutinib Compared with Ibrutinib

Retrieved on: 
Friday, June 11, 2021

Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.

Key Points: 
  • Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.
  • The activity and tolerability of zanubrutinib have been demonstrated in patients with CLL/SLL in early phase clinical trials.
  • The ALPINE study solidifies the findings of these pivotal trials by a head-to-head comparison of the safety and efficacy of zanubrutinib and ibrutinib in 415 patients with relapsed/refractory CLL/SLL.
  • In summary, zanubrutinib showed more selective inhibition of BTK resulting in improved efficacy and safety compared with ibrutinib.

X4 Pharmaceuticals Announces Presentation of Positive Data from Ongoing Phase 1b Clinical Trial of Mavorixafor in Waldenström’s Macroglobulinemia at EHA 2021

Retrieved on: 
Friday, June 11, 2021

We are very pleased to present this exciting first look at the data from our ongoing Phase 1b trial in double-mutation Waldenstrms patients, said Diego Cadavid, M.D., Chief Medical Officer of X4 Pharmaceuticals.

Key Points: 
  • We are very pleased to present this exciting first look at the data from our ongoing Phase 1b trial in double-mutation Waldenstrms patients, said Diego Cadavid, M.D., Chief Medical Officer of X4 Pharmaceuticals.
  • We look forward to presenting longer-term data and an expanded data set from this trial later in the year.
  • Mavorixafor exposures tracked with sustained and dose-dependent increases in white blood cell counts, confirming target engagement and mavorixafor mechanism of action.
  • The e-poster (EP784) entitled: Preliminary Clinical Data From a Phase 1b Study of Mavorixafor and Ibrutinib in Patients With Waldenstrms Macroglobulinemia With MYD88 and CXCR4 Mutations is now available on the X4 corporate website .

Final Data from Calithera Biosciences’ Phase 2 CANTATA Study in Renal Cell Carcinoma Presented at 2021 ASCO Annual Meeting

Retrieved on: 
Monday, June 7, 2021

The findings were highlighted in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.

Key Points: 
  • The findings were highlighted in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.
  • Results announced previously showed that the addition of telaglenastat to cabozantinib did not improve progression-free survival (PFS) in the study population.
  • Median progression-free survival (mPFS) in patients who received telaglenastat and cabozantinib was 9.2 months versus 9.3 months in patients who received placebo and cabozantinib.
  • The frequency and severity of adverse events in the telaglenastat-treated population were comparable to those of cabozantinib alone and remained consistent with known risks of both agents.

CALQUENCE Demonstrated Fewer Incidences of Atrial Fibrillation Versus Ibrutinib in Previously Treated Patients With Chronic Lymphocytic Leukemia and Sustained Patient Benefit at Four Years in the Front-line Setting

Retrieved on: 
Monday, June 7, 2021

In clinical trials, major hemorrhage occurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% of patients taking CALQUENCE with antithrombotic agents.

Key Points: 
  • In clinical trials, major hemorrhage occurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% of patients taking CALQUENCE with antithrombotic agents.
  • Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (8%), thrombocytopenia (7%), and lymphopenia (7%), developed in patients with hematologic malignancies treated with CALQUENCE.
  • Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 patients treated with CALQUENCE, with all grades of atrial fibrillation or flutter reported in 4.1% of all patients.
  • First Results of a Head-to-Head Trial of Acalabrutinib versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia.

Global Waldenstrom Macroglobulinemia (WM) Market Spotlight Report 2021: Treatments, Epidemiology, Disease Background, Pipeline, Recent Events, Opportunity, Clinical Trials, Marketed Drugs - ResearchAndMarkets.com

Retrieved on: 
Friday, June 4, 2021

This Market Spotlight report covers the Waldenstrom Macroglobulinemia (WM) market, comprising key marketed and pipeline drugs, probability of success, clinical trials, upcoming events, recent events and analyst opinion, a 10-year disease incidence forecast, and presenting drug-specific revenue forecasts.

Key Points: 
  • This Market Spotlight report covers the Waldenstrom Macroglobulinemia (WM) market, comprising key marketed and pipeline drugs, probability of success, clinical trials, upcoming events, recent events and analyst opinion, a 10-year disease incidence forecast, and presenting drug-specific revenue forecasts.
  • Imbruvica and tirabrutinib, two small molecule tyrosine kinase inhibitors, are the only marketed drugs for WM.
  • The majority of industry-sponsored drugs in active clinical development for WM are in Phase II, with only two drugs in Phase III.
  • Bristol Myers Squibb, Johnson & Johnson, and Takeda lead the industry sponsors with the highest overall number of clinical trials for WM.

BeiGene Announces First Presentation of the Phase 3 ALPINE Trial Comparing BRUKINSA® (Zanubrutinib) to Ibrutinib in Chronic Lymphocytic Leukemia to Be Featured in Presidential Symposium at EHA2021

Retrieved on: 
Tuesday, June 1, 2021

The abstract has also been selected by the Scientific Program Committee to be highlighted in the EHA2021 Virtual Press Briefing.

Key Points: 
  • The abstract has also been selected by the Scientific Program Committee to be highlighted in the EHA2021 Virtual Press Briefing.
  • We look forward to the first presentation of these data in the Presidential Symposium at EHA.
  • Results from the interim analysis were based on 415 enrolled patients in the trial, including 207 on BRUKINSA treatment and 208 on ibrutinib treatment.
  • A live webcast of the conference call can be accessed from the investors section of BeiGenes website at http://ir.beigene.com or http://hkexir.beigene.com .

Kronos Bio Announces Participation in Upcoming Investor Conferences

Retrieved on: 
Wednesday, May 26, 2021

The fireside chats will be webcast live from the Investors & Media section of the companys website at www.kronosbio.com .

Key Points: 
  • The fireside chats will be webcast live from the Investors & Media section of the companys website at www.kronosbio.com .
  • Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer.
  • Kronos Bio is developing a portfolio of spleen tyrosine kinase (SYK) inhibitors, entospletinib (ENTO) and lanraplenib (LANRA), for the treatment of NPM1-mutated and FLT3-mutated acute myeloid leukemia (AML).
  • Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass.

TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with UKONIQ® (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Retrieved on: 
Tuesday, May 25, 2021

The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.

Key Points: 
  • The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.
  • FDA previously granted Fast Track designation to the combination of ublituximab and UKONIQ for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with UKONIQ for the treatment of CLL.
  • The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm.
  • Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia.

RYBREVANT™ (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Friday, May 21, 2021

EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics.Molecular Cancer Therapeutics.2013; Feb; 12(2):220-9.\n3Key Statistics in Lung Cancer.

Key Points: 
  • EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics.Molecular Cancer Therapeutics.2013; Feb; 12(2):220-9.\n3Key Statistics in Lung Cancer.
  • Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations.
  • Accessed May 2021.\n14Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer.
  • Accessed May 2021.\n15Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.

China Ibrutinib Market Report 2021: By 2020, Pharmacyclics Inc is the Only Manufacturer in the Chinese Market - Forecast to 2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, May 20, 2021

Their Ibrutinib, IMBRUVICA was launched in China in 2017.\nAccording to this market research, after Ibrutinib entered the Chinese market, the sales value of Ibrutinib in China has increased from CNY48,600 in 2017 to CNY 345.5 million in 2020.

Key Points: 
  • Their Ibrutinib, IMBRUVICA was launched in China in 2017.\nAccording to this market research, after Ibrutinib entered the Chinese market, the sales value of Ibrutinib in China has increased from CNY48,600 in 2017 to CNY 345.5 million in 2020.
  • In 2020, the growth rate was 38.2%, which slowed down due to the COVID-19 epidemic.
  • On the other hand, China approves fewer indications for Ibrutinib than other countries do.
  • Therefore, the number of approved indications has the potential to increase, which means the market will keep expanding in the future.\n2 Sales of Ibrutinib in China, 2017-2020\n2.3 Sales of Ibrutinib by Dosage Form in China, 2017-2020\n3 Analysis of Major Ibrutinib Manufacturers in China, 2017-2020\n4 Prices of Ibrutinib for Different Manufacturers in China, 2020-2021\n5 Prospect of Chinese Ibrutinib drug Market, 2021-2025\n'