Quinazolines

Affimed Announces Publication of Comprehensive Preclinical Data Demonstrating the Therapeutic Potential of AFM24 in EGFR-expressing Tumors

Retrieved on: 
Friday, July 30, 2021

Preclinical data demonstrate AFM24s activation of the innate immune system, acting independently of EGFR-expression levels, EGFR-pathway mutations and downstream signal transduction.

Key Points: 
  • Preclinical data demonstrate AFM24s activation of the innate immune system, acting independently of EGFR-expression levels, EGFR-pathway mutations and downstream signal transduction.
  • The published data supported the Investigational New Drug application for the ongoing AFM24 Phase 1/2a dose escalation study.
  • The published data were the basis for the Investigational New Drug (IND) clearance for Affimeds ongoing Phase 1/2a study with AFM24 monotherapy in patients with EGFR expressing solid tumors.
  • AFM24 is effective against many EGFR-positivetumorcells, regardless of EGFR expression level and KRAS/BRAF mutational status within in vitro studies.

HUTCHMED and AstraZeneca Initiate Phase II Trial of ORPATHYS® in Patients with MET Amplified Gastric Cancer

Retrieved on: 
Wednesday, July 28, 2021

Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).

Key Points: 
  • Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).
  • ORPATHYS is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors.
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize ORPATHYS.
  • Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China.

Sol-Gel Technologies to Report Second Quarter 2021 Financial Results on August 4th, 2021

Retrieved on: 
Tuesday, July 20, 2021

NESS ZIONA, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.

Key Points: 
  • NESS ZIONA, Israel, July 20, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, will report second quarter 2021 financial results on Wednesday, August 4, 2021 at 7:05 AM ET.
  • Both product candidates are exclusively licensed forU.S.commercialization withGalderma Holding SA.
  • The Companys pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment ofpalmoplantar keratoderma, and preclinical assets tapinarof and roflumilast.
  • For additional information, please visit www.sol-gel.com .

HUTCHMED announces savolitinib approved in China for patients with lung cancer with MET exon 14 skipping alterations

Retrieved on: 
Tuesday, June 22, 2021

Approximately 2-3% of newly diagnosed NSCLC patients have MET exon skipping 14 alterations, a specific genetic mutation.

Key Points: 
  • Approximately 2-3% of newly diagnosed NSCLC patients have MET exon skipping 14 alterations, a specific genetic mutation.
  • Savolitinib is an oral, potent and selective MET TKI that has demonstrated clinical activity in advanced solid tumors.
  • It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations).
  • HUTCHMED is responsible for the manufacturing and supply of savolitinib, and AstraZeneca is responsible for its commercialization in China and worldwide.

Puma Biotechnology Presents Data from the EGFR Exon 18-mutant NSCLC Cohort of the Phase II SUMMIT Trial at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC).

Key Points: 
  • The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC).
  • A cohort of 11 patients with EGFR exon 18-mutant NSCLC from the Phase II SUMMIT basket trial, including patients with central nervous system involvement, were evaluated for safety and efficacy.
  • Prior lines of therapies included EGFR tyrosine kinase inhibitors (TKIs) (91%), chemotherapy (55%) and checkpoint inhibitors (IOs) (27%).
  • These results suggest that neratinib can be a potential treatment option for patients with NSCLC and hard-to-treat CNS metastases.

Cullinan Oncology Announces Phase 1/2a Interim Data For Cullinan Pearl’s CLN-081 in NSCLC EGFR Exon 20 Patients

Retrieved on: 
Friday, June 4, 2021

CLN-081 is an orally available, irreversible EGFR inhibitor, utilizing a unique pyrrolopyrimidine scaffold that was designed to selectively target cells expressing mutant EGFR variants, including exon 20, while sparing cells expressing wild type (WT) EGFR.

Key Points: 
  • CLN-081 is an orally available, irreversible EGFR inhibitor, utilizing a unique pyrrolopyrimidine scaffold that was designed to selectively target cells expressing mutant EGFR variants, including exon 20, while sparing cells expressing wild type (WT) EGFR.
  • The current analysis of the ongoing trial evaluated a total of 45 NSCLC patients with EGFR exon 20 insertion mutations who received at least one dose of CLN-081 as of the April 1, 2021, data cutoff, and were evaluable for safety.
  • As of the data cutoff, 42 of 45 patients were response evaluable across all dose cohorts tested.
  • Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring Ins20 mutations that have progressed post chemotherapy.

Seagen Announces Long-Term Results from TUKYSA® (tucatinib) Pivotal Trial in Patients with HER2-Positive Breast Cancer During the Virtual Scientific Program of the 2021 ASCO Annual Meeting

Retrieved on: 
Thursday, June 3, 2021

Data from the pre-specified exploratory analysis will be presented (Abstract #1043) as part of the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • Data from the pre-specified exploratory analysis will be presented (Abstract #1043) as part of the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • These results support the significant impact that a TUKYSA regimen can have for patients with HER2-positive metastatic breast cancer, said Roger D. Dansey, M.D., Chief Medical Officer of Seagen.
  • Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients.
  • Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.

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.

Aumolertinib Significantly Prolongs Progression-Free Survival with Fewer Side Effects in the First-Line Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, May 19, 2021

Results of AENEAS suggest aumolertinib may possess truly differentiated benefits for patients in terms of efficacy and tolerability,\xe2\x80\x9d commented Vincent Miller, M.D., physician-in-chief of EQRx.

Key Points: 
  • Results of AENEAS suggest aumolertinib may possess truly differentiated benefits for patients in terms of efficacy and tolerability,\xe2\x80\x9d commented Vincent Miller, M.D., physician-in-chief of EQRx.
  • The median PFS was estimated at 19.3 months for aumolertinib and 9.9 months for gefitinib with a hazard ratio 0.46 (p
  • Improvement in PFS in patients who received aumolertinib over gefitinib was observed across relevant subgroups of patients, including those with brain metastases.
  • Adverse events that caused patients to temporarily stop or discontinue treatment altogether were less common with aumolertinib than with gefitinib.

Tiziana Announces Strategic Initiative with Takanawa Japan K.K., Pharma Team, to Identify a Partner in Japan and Other Asian Countries for Further Clinical Development of Milciclib in Patients with Advanced Hepatocellular Carcinoma.

Retrieved on: 
Wednesday, May 5, 2021

The clinical data, presented at the American Society of Clinical Oncology (ASCO)1, demonstrated that the treatment was well-tolerated and produced clinical activity.

Key Points: 
  • The clinical data, presented at the American Society of Clinical Oncology (ASCO)1, demonstrated that the treatment was well-tolerated and produced clinical activity.
  • Recently, a patent covering the use of Milciclib in combination with a tyrosine kinase inhibitor (TKI) or other drugs was granted2.
  • The granted claims provide complete freedom to further develop a combination of Milciclib with an approved TKI for treatment of patients with advanced HCC or other cancers.
  • Takanawa also supports companies entering the Japanese and Asian market as well as Japanese companies to enter overseas markets.