Antineoplastic drugs

BioInvent to Host Key Opinion Leader Call on Enhancing Checkpoint Inhibitors for the Treatment of Solid Cancers

Retrieved on: 
Monday, July 13, 2020
Cancer treatments, Clinical medicine, Medicine, Antineoplastic drugs, Breakthrough therapy, Immune system, Merck, Pembrolizumab, Programmed cell death protein 1, Oncology, Melanoma, Cancer immunotherapy

BioInvent recently announced the enrolment of the first patient in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with solid tumors.

Key Points: 
  • BioInvent recently announced the enrolment of the first patient in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with solid tumors.
  • BioInvent's management and Prof. Eggermont will be available to answer questions at the conclusion of the call.
  • Eggermont, MD, PhD is an internationally recognized expert in surgical oncology, immunotherapy, melanoma, sarcoma and cancer drug development.
  • Two preclinical programs in solid tumors are expected to enter clinical trials by the end of 2020.

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for Second-Line Treatment of Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Retrieved on: 
Thursday, July 9, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Cancer treatments, Cancer, Clinical medicine, RTT, Antineoplastic drugs, Breakthrough therapy, Non-Hodgkin lymphoma, Anatomical pathology, Lymphoma, Pembrolizumab, Hodgkin's lymphoma, Nivolumab, KEYNOTE-204, Hodgkin Lymphoma, Merck

We look forward to working with the FDA to bring KEYTRUDA to more patients with classical Hodgkin lymphoma after initial treatment.

Key Points: 
  • We look forward to working with the FDA to bring KEYTRUDA to more patients with classical Hodgkin lymphoma after initial treatment.
  • Classical Hodgkin lymphoma accounts for more than nine in 10 cases of Hodgkin lymphoma in developed countries.
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy.

Eisai and Merck Receive Complete Response Letter for LENVIMA (lenvatinib) plus KEYTRUDA (pembrolizumab) Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma

Retrieved on: 
Thursday, July 9, 2020
Cancer treatments, Clinical medicine, Drugs, Antineoplastic drugs, Breakthrough therapy, Merck, Pembrolizumab, Lenvatinib

The applications were based on data from the Phase 1b Study 116/KEYNOTE-524 trial, which showed clinically meaningful efficacy in the single-arm setting.

Key Points: 
  • The applications were based on data from the Phase 1b Study 116/KEYNOTE-524 trial, which showed clinically meaningful efficacy in the single-arm setting.
  • Ahead of the PDUFA action dates of Eisai's and Merck's applications, another combination therapy was approved based on a randomized controlled trial that demonstrated overall survival.
  • As such, LEAP-002, the Phase 3 trial evaluating the LENVIMA plus KEYTRUDA combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled.
  • Eisai and Merck are continuing to evaluate the LENVIMA plus KEYTRUDA combination across 13 different tumor types in 18 clinical trials including the LEAP (LEnvatinib And Pembrolizumab) clinical program.

TG Therapeutics Announces Publication in Blood Advances Describing Unique Immunomodulatory Effects on CLL T cells by Umbralisib

Retrieved on: 
Wednesday, July 8, 2020
Medicine, Clinical medicine, Cancer, Antineoplastic drugs, Oncology, Immune system, Purines, Umbralisib, Duvelisib, Idelalisib, Phosphoinositide 3-kinase, Casein kinase 1 isoform epsilon, Medicine, Clinical medicine, Cancer, Antineoplastic drugs, Oncology, Immune system, Purines, Umbralisib, Duvelisib, Idelalisib, Phosphoinositide 3-kinase, Casein kinase 1 isoform epsilon

NEW YORK, July 08, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of preclinical data describing the unique immunomodulatory effects of umbralisib, the Companys investigational oral once-daily dual inhibitor of PI3K-delta and CK1-epsilon, in Blood Advances, a Journal of the American Society of Hematology.

Key Points: 
  • NEW YORK, July 08, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of preclinical data describing the unique immunomodulatory effects of umbralisib, the Companys investigational oral once-daily dual inhibitor of PI3K-delta and CK1-epsilon, in Blood Advances, a Journal of the American Society of Hematology.
  • We are pleased to contribute to elucidating the mechanisms of umbralisib and look forward to continuing our research.
  • The manuscript included preclinical data describing the effects of idelalisib, duvelisib and umbralisib on regulatory T cells (Tregs) on normal human T cells, T cells from CLL patients and T cells in an E-TCL1 adoptive transfer mouse CLL model.
  • These data are described further in the manuscript entitled, The dual PI3K delta/CK1 epsilon inhibitor umbralisib exhibits unique immunomodulatory effects on CLL T cells, which was published online in the First Edition section of Blood Advances, the Journal of the American Society of Hematology.

Merck and Eisai Receive Complete Response Letter for KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma

Retrieved on: 
Wednesday, July 8, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Clinical medicine, Medicine, Cancer, Chloroarenes, Orphan drugs, Ureas, Hepatology, Antineoplastic drugs, Merkel-cell carcinoma, Pembrolizumab, Sorafenib, Hepatocellular carcinoma, LENVIMA® (lenvatinib) Capsules, 10 mg and 4 mg, Merck, Eisai

As such, LEAP-002, the Phase 3 trial evaluating the KEYTRUDA plus LENVIMA combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled.

Key Points: 
  • As such, LEAP-002, the Phase 3 trial evaluating the KEYTRUDA plus LENVIMA combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled.
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer

Retrieved on: 
Monday, July 6, 2020
FDA, Other Health, Health, Pharmaceutical, Oncology, Medicine, Clinical medicine, Cancer treatments, Genentech, RTT, Antineoplastic drugs, Immunology, Trastuzumab, HER2/neu, Breast cancer, Metastatic breast cancer, Trastuzumab emtansine, HER2, HER2 Positive Breast Cancer, Trastuzumab Deruxtecan, Daiichi Sankyo

Trastuzumab deruxtecan was granted accelerated assessment by the EMAs Committee for Medicinal Products for Human Use (CHMP).

Key Points: 
  • Trastuzumab deruxtecan was granted accelerated assessment by the EMAs Committee for Medicinal Products for Human Use (CHMP).
  • The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing, said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo.
  • The MAA is based on the positive results from the pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2 regimens.
  • Trastuzumab deruxtecan (5.4 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial.

2020 Insights into Head and Neck Cancer Disease Industry - Coverage Forecast and Market Analysis to 2024 - ResearchAndMarkets.com

Retrieved on: 
Friday, July 3, 2020
Health, Oncology, Clinical medicine, Medicine, Cancer, Antineoplastic drugs, Breakthrough therapy, Cancer treatments, Virotherapy, RTT, Pembrolizumab, Nivolumab, Immunotherapy, Head and neck cancer

The majority of HNC diagnoses (75.2%) worldwide are in males, ranging from 64.9% to 76.3% across regions.

Key Points: 
  • The majority of HNC diagnoses (75.2%) worldwide are in males, ranging from 64.9% to 76.3% across regions.
  • Though a heterogenous group of diseases, the overwhelming majority (90%) of HNCs are comprised of squamous cell carcinomas of the head and neck (HNSCCs).
  • As such, there has been much interest in the development of immunotherapies to allow for a more targeted treatment program.
  • The first immunotherapies approved for recurrent/metastatic HNSCCs are the checkpoint inhibitors Keytruda (for first and second line) and Opdivo (second line only).

Calithera Biosciences Announces New Employment Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, July 2, 2020
Life sciences, Articles, Antineoplastic drugs, Biopharmaceutical, Biotechnology, Pharmaceutical industry, Pharmacy, Targeted therapy

One-fourth of the options vest in June 2021, and the balance of the options vest in a series of thirty-six successive equal monthly installments thereafter and was granted pursuant to the Calithera Biosciences, Inc. 2018 Inducement Plan, or Inducement Plan, which was approved by Calitheras board of directors in January 2018 in accordance with Nasdaq Listing Rule 5653(c)(4).

Key Points: 
  • One-fourth of the options vest in June 2021, and the balance of the options vest in a series of thirty-six successive equal monthly installments thereafter and was granted pursuant to the Calithera Biosciences, Inc. 2018 Inducement Plan, or Inducement Plan, which was approved by Calitheras board of directors in January 2018 in accordance with Nasdaq Listing Rule 5653(c)(4).
  • The stock options also have a ten year term and are subject to the terms and conditions of the Inducement Plan and the stock option agreement pursuant to which the options were granted.
  • Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially block tumor cells and enhance immune-cell activity.
  • The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all.

Global Small Molecule Cancer Drug Market to 2026 - Drug Price, Dosage & Clinical Trials Insight - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 2, 2020
Health, Pharmaceutical, Medicine, Clinical medicine, Cancer, Cancer treatments, Antineoplastic drugs, Chemotherapy, Occupational safety and health, Oncology, Treatment of cancer, Tyrosine kinase inhibitors, Birabresib, Vascular-targeting agent

The "Global Small Molecule Cancer Drug Market, Drug Price, Dosage & Clinical Trials Insight 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Small Molecule Cancer Drug Market, Drug Price, Dosage & Clinical Trials Insight 2026" report has been added to ResearchAndMarkets.com's offering.
  • The basic targeting advantage along with the dominance of small molecule drugs in cancer clinical pipeline will drive the global small molecule cancer drug market in coming years.
  • Small Molecule Cancer Drug Market Opportunity: More Than US$ 125 Billion by 2026
    USA Dominates The Global Small Molecule Cancer Drug Market: >50% Share
    Small Molecule Cancer Drug Market Clinical Trials: >2500 Drugs
    Small Molecule Cancer Drugs Dosage, Sales, Price & Patent Insight: 175 Drugs
    Clinical Trials Insight by Phase, Company, Country, Formulation, Indication
    An important parameter that should be associated with any of the cancer treatment is its specificity.
  • 3.2 Small Molecule Cancer Drug vs. Immunotherapy
    3.3 Small Molecule Cancer Drugs vs.

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Wednesday, July 1, 2020
Antineoplastic drugs, Chemical compounds, Selective inhibitor of nuclear export, Selinexor, XPO1, SINE

The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Each of the stock options has an exercise price of$18.94 per share, the closing price of Karyopharms common stock on June 30, 2020.
  • Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1).
  • InJune 2020, XPOVIO was approved by the FDA as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma.