TKI

Exelixis and Arcus Biosciences Announce Clinical Trial Collaboration to Evaluate Zanzalintinib in Combination with AB521 in Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
Monday, December 4, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Exelixis, NYSE, Patient, Multimedia, TKI, Kidney cancer, Medical Affairs Bureau, ClinicalTrials.gov, Pharmaceutical industry

Exelixis, Inc. (Nasdaq: EXEL) and Arcus Biosciences (NYSE: RCUS) today announced that the companies have entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor (TKI), in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) and Arcus Biosciences (NYSE: RCUS) today announced that the companies have entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor (TKI), in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC).
  • Exelixis is sponsoring STELLAR-009, and Arcus is co-funding the study and providing AB521 for use in the trial.
  • Patient enrollment for STELLAR-009 is expected to begin before the end of 2023.
  • More information about this trial will be available soon on ClinicalTrials.gov.

AnHeart Therapeutics and Innovent Announce China’s NMPA Has Accepted a New Drug Application for Taletrectinib (ROS1 Inhibitor)

Retrieved on: 
Wednesday, November 22, 2023
FDA, Pharmaceutical, Health, Oncology, NDA, Ophthalmology, HKEX, National Medical Products Administration, Senior, NMPA, Brain, Patient, CDE, ROS1, New Drug Application, TKI, MD, Cancer, ELCC, NSCLC, Pharmaceutical industry, Hong Kong

The NDA acceptance in China is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.

Key Points: 
  • The NDA acceptance in China is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.
  • Results from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023 .
  • “Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally.
  • We would like to thank all the doctors and patients who participated in the clinical trials that support this submission,” said Bing Yan, MD, Chief Medical Officer, AnHeart.

Avistone Announces the First Approval of Vebreltinib for MET Exon 14 Skipping Non-Small Cell Lung Cancer Opening a New Chapter in MET-targeted Treatment of Lung Cancer

Retrieved on: 
Friday, November 17, 2023
Research, Medical Devices, Genetics, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, National Medical Products Administration, Progression-free survival, Cell proliferation, NMPA, ESMO, Patient, PFS, Fusion, Lung cancer, Neoplasm, Therapy, TKI, ORR, MET, Survival, Congress, EGFR, Pharmaceutical industry, Hong Kong, NSCLC

MET signaling is implicated in cell proliferation, migration, invasion, and survival.

Key Points: 
  • MET signaling is implicated in cell proliferation, migration, invasion, and survival.
  • Genomic alterations in MET can manifest in driving oncogenesis in the form of MET exon 14 skipping (METex14) or other activating mutations, MET gene amplification, gene fusion and MET protein overexpression.
  • With the NMPA approval of Vebreltinib, we look forward to providing this new treatment option to patients with MET exon 14 skipping NSCLC in China” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone.
  • Avistone is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally.

U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, November 16, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Clinician Administered PTSD Scale, CNS, Assistant, Brain, Bristol Myers Squibb, NYSE, Food, Hope, ILD, Disease, Hepatotoxicity, Patient, BMY, ROS1, Harvard Medical School, TKI, ORR, Cancer, Massachusetts General Hospital, Central nervous system, Confidence interval, Myalgia, Hospital, NSCLC, Pharmaceutical industry, Nursing, Hyperuricemia, Medicine, MD

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).1 Administered as an oral therapy, Augtyro is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).1 Administered as an oral therapy, Augtyro is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.1
    The approval is based on the TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated Augtyro in TKI-naïve and TKI-pretreated patients.2 In TKI-naïve patients (n=71), the primary endpoint of objective response rate (ORR), defined as the percentage of people treated within a certain period of time whose tumor size decreased (partial response) or who no longer have signs of cancer (complete response), was 79% (95% Confidence Interval [CI]: 68 to 88).1,3 The median duration of response (mDOR) was 34.1 months.
  • Among patients pretreated with one prior ROS1 TKI and no prior chemotherapy (n=56), the ORR was 38% (95% CI: 25 to 52) and the mDOR was 14.8 months.1 Among those who had measurable central nervous system (CNS) metastases at baseline, responses in intracranial lesions were observed in 7 of 8 TKI-naïve patients (n=71) and 5 of 12 of those who were TKI-pretreated (n=56).1
    “New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” said Jessica J. Lin, MD, TRIDENT-1 primary investigator and attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital and Assistant Professor of Medicine at Harvard Medical School.4,5,6,7 “Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer.”1
    Augtyro is associated with the following Warnings & Precautions: central nervous system (CNS) effects, interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.1 Please see Important Safety Information below.
  • “While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” said Samit Hirawat, MD , executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb.6,7 “As the only approved next-generation TKI for ROS1-positive NSCLC patients, Augtyro builds on our legacy of delivering transformational therapies for patients with thoracic cancers.”6,8,9
    “ROS1-positive NSCLC patients and their families face a stressful journey because our cancer can be difficult to treat, especially when it spreads to the brain,” said Janet Freeman-Daily, co-founder and president of The ROS1ders, a patient advocacy organization.10 “Today’s approval brings a new treatment option for the ROS1-positive patient community, which gives us hope for more time with loved ones.”
    Augtyro is designed to minimize interactions that can lead to certain forms of treatment resistance in ROS1-positive metastatic NSCLC patients.6,8,11 It is expected to be available to patients in the U.S. in mid-December 2023.
  • Bristol Myers Squibb thanks the patients and investigators involved in the TRIDENT-1 clinical trial program.

Exelixis Announces Encouraging Results from Expansion Cohort of Phase 1b STELLAR-001 Trial Evaluating Zanzalintinib in Patients with Advanced Kidney Cancer at IKCS 2023

Retrieved on: 
Friday, November 10, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, City, Exelixis, Patient, TKI, CST, VEGFR, Immunotherapy, HIV disease progression rates, Pharmaceutical industry

Exelixis, Inc. (Nasdaq: EXEL) today announced initial results from an expansion cohort of STELLAR-001 evaluating single-agent zanzalintinib in patients with previously treated clear cell renal cell carcinoma (ccRCC).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced initial results from an expansion cohort of STELLAR-001 evaluating single-agent zanzalintinib in patients with previously treated clear cell renal cell carcinoma (ccRCC).
  • STELLAR-001 is a phase 1b trial evaluating zanzalintinib alone and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors.
  • The findings are being presented today at 2:35 p.m. CST during the Oral Abstracts session at the 2023 International Kidney Cancer Symposium (IKCS): North America.
  • Eighty-one percent of patients were intermediate risk by International Metastatic RCC Database Consortium.

Live from ASH 2023 | Results from Chinese Studies of Olverembatinib Presented in Oral Report at the ASH Annual Meeting for the Sixth Consecutive Year, Including Data Showing Promising Efficacy in Patients with TKI-Resistant and/or Intolerant CML-CP

Retrieved on: 
Wednesday, December 13, 2023
Hydroxycarbamide, Research, Intolerance, Dasatinib, HHT, Aes, Incidence, ASH, Risk, NMPA, TKI, Eastern Cooperative Oncology Group, Hematology, Disease, Hospital, Patient, Nilotinib, QOD, Pacific Time Zone, BCR, Pacific Ocean, CHB, Prognosis, Natural product, ECOG, Cancer, CML, Death, R, Hepatitis, Society, Notifiable disease, BAT, HIV disease progression rates, Pharmaceutical industry, Nursing, EFS

This is the sixth consecutive year in which study results on olverembatinib have been selected for Oral Presentations at the ASH Annual Meeting.

Key Points: 
  • This is the sixth consecutive year in which study results on olverembatinib have been selected for Oral Presentations at the ASH Annual Meeting.
  • After reaching EFS, patients in the BAT arm were allowed to cross-over to the olverembatinib arm for continued treatment.
  • Patients: As of October 17, 2023, a total of 144 patients were enrolled, of whom 96 patients received olverembatinib and 48 received BAT.
  • In addition, the olverembatinib arm has shown a higher cumulative response rate and longer duration of responses.

Lung Cancer Research Foundation and the International Association for the Study of Lung Cancer (IASLC) Announce New Research Partnership

Retrieved on: 
Tuesday, December 5, 2023
Research, Organization, NTRK, International Association, TKI, Patient, ROS1, Death, FDA, Neoplasm, Lung cancer, Science of team science, Request, BRAF, HER2, Cancer, MET, Partnership, RET, Coronavirus Scientific Advisory Board, EGFR, Estate (law), Pharmaceutical industry

NEW YORK, Dec. 5, 2023 /PRNewswire/ -- The Lung Cancer Research Foundation (LCRF) and the International Association for the Study of Lung Cancer (IASLC) today announced a new research partnership, titled IASLC - LCRF Team Science Research Grant on the Next Step in the Cure of Oncogene-Driven Lung Cancers.

Key Points: 
  • NEW YORK, Dec. 5, 2023 /PRNewswire/ -- The Lung Cancer Research Foundation (LCRF) and the International Association for the Study of Lung Cancer (IASLC) today announced a new research partnership, titled IASLC - LCRF Team Science Research Grant on the Next Step in the Cure of Oncogene-Driven Lung Cancers.
  • Lung cancer is responsible for more deaths worldwide than any other cancer, accounting for an estimated 130,180 deaths annually in the United States alone.
  • "Resistance in oncogene-driven lung cancers is a frustrating inevitability for these patients," says Dr. Antoinette Wozniak, Chief Scientific Officer for LCRF.
  • "We're pleased to be collaborating with LCRF to create this Team Science award to work on curing oncogenic-driven lung cancers."

Ascentage Pharma Hosts Ceremony Marking the Launch of Olverembatinib in Newly Approved Indication and the Dispatch of First Batch for the New Indication

Retrieved on: 
Friday, November 24, 2023
NDA, Bone marrow, Priority review, Safety, National Medical Products Administration, BAT, Leukemia, EFS, New Drug Application, NMPA, TKI, CDE, Patient, BTD, Imatinib, Trust, Nilotinib, Therapy, BCR-ABL, CML, Death, Survival, NRDL, Government, Mutation, HIV disease progression rates, Pharmaceutical industry

Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).

Key Points: 
  • Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China.
  • Ascentage Pharma and Innovent are mutually committed to the commercialization of olverembatinib in the China market.
  • Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up.

Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Accepted the New Drug Application for Taletrectinib (ROS1 Inhibitor)

Retrieved on: 
Wednesday, November 22, 2023
NDA, National Medical Products Administration, Oncology, Ophthalmology, HKEX, Senior, New Drug Application, NMPA, Brain, Patient, CDE, Yan, ROS1, TKI, MD, Cancer, ELCC, Hospital, NSCLC, Pharmaceutical industry, Hong Kong

The NDA acceptance are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.

Key Points: 
  • The NDA acceptance are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.
  • I hope this NDA represents a step towards making another option available to the ROS1-positive NSCLC patient community in China."
  • Bing Yan, MD, Chief Medical Officer of AnHeart, stated: "Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally.
  • In June 2021, Innovent and AnHeart entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

DASYNOC™ Uptake into the Blood Remains Consistent When Taken with Omeprazole, Whereas SPRYCEL® Uptake is Significantly More Impaired than Previously Understood

Retrieved on: 
Wednesday, November 8, 2023
Biotechnology, Pharmaceutical, Health, Oncology, PH, FDA, AUC, PPI, Omeprazole, Physician, CML, HIV disease progression rates, Dasatinib, Risk, TKI, Blood, Patient, Death, Solubility, Pharmaceutical industry, Cmax

Xspray has demonstrated that in the DASYNOC CO-PPI Study, DASYNOC’s uptake into blood was not affected 10 hours after taking omeprazole (107 % of intended AUC0-24h and 86% of intended Cmax).

Key Points: 
  • Xspray has demonstrated that in the DASYNOC CO-PPI Study, DASYNOC’s uptake into blood was not affected 10 hours after taking omeprazole (107 % of intended AUC0-24h and 86% of intended Cmax).
  • However, in the SPRYCEL CO-PPI Study, the uptake of SPRYCEL was significantly reduced 10 hours after taking omeprazole (only 12% of the intended AUC0-24h and 4% of the intended Cmax).
  • “We recently published that CML patients, concomitantly treated with TKIs and PPIs, are at a statistically significant 3.5-fold increased risk of death.
  • SPRYCEL was approved in 2006 by the FDA and is the market leading branded product that revolutionized the treatment of CML.