Antineoplastic drugs

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as a Single Agent After Surgery Showed Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

Retrieved on: 
Thursday, July 15, 2021
Other Health, Research, General Health, Pharmaceutical, Oncology, Infectious diseases, Clinical trials, Science, Biotechnology, FDA, Other Science, Health, Clinical medicine, Health sciences, Cancer treatments, Orphan drugs, Breakthrough therapy, Antineoplastic drugs, Cancer immunotherapy, Pembrolizumab, Adjuvant therapy, Neoadjuvant therapy, Therapy, Programmed cell death protein 1, Triple-Negative Breast Cancer (TNBC), Merck, TRIPLE-NEGATIVE BREAST CANCER (TNBC), MERCK

This is the first time an anti-PD-1/L1 therapy has demonstrated a statistically significant EFS result as combined neoadjuvant and adjuvant therapy for these patients.

Key Points: 
  • This is the first time an anti-PD-1/L1 therapy has demonstrated a statistically significant EFS result as combined neoadjuvant and adjuvant therapy for these patients.
  • KEYNOTE-522 was designed to study whether the combined neoadjuvant and adjuvant regimen with KEYTRUDA could help treat the cancer earlier.
  • Immune-mediated AEs led to death in 0.3% of patients receiving the KEYTRUDA regimen (n=2) and no patients receiving the chemotherapy-placebo regimen.
  • KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

ImmunoGen Announces Conference Call to Discuss Its Second Quarter 2021 Operating Results

Retrieved on: 
Thursday, July 15, 2021
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Clinical medicine, Medical specialties, Medicine, Immunology, Antineoplastic drugs, Biotechnology, Antibody-drug conjugate, ImmunoGen, ImmunoGen, Monoclonal antibodies

ET on Friday, July 30, 2021 to discuss its second quarter operating results.

Key Points: 
  • ET on Friday, July 30, 2021 to discuss its second quarter operating results.
  • To access the live call by phone, dial (877) 621-5803; the conference ID is 1789134.
  • The call may also be accessed through the Investors and Media section of the Companys website, www.immunogen.com .
  • ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients.

GigaGen Publishes Research Describing Novel Mechanism of Action and Therapeutic Potential of its anti-CTLA-4 Drug Candidate, GIGA-564

Retrieved on: 
Wednesday, July 14, 2021
Clinical medicine, Medicine, Branches of biology, T cells, Immune system, Clusters of differentiation, Cancer immunotherapy, Antineoplastic drugs, Checkpoint inhibitor, Regulatory T cell, CTLA-4, Chemotherapy

The publication describes the novel mechanism of action of its anti-CTLA-4 drug candidate, GIGA-564, selected due to its reduced checkpoint inhibition, which resulted in superior anti-tumor activity and lower toxicity in murine models compared to commercially available anti-CTLA-4 drugs.

Key Points: 
  • The publication describes the novel mechanism of action of its anti-CTLA-4 drug candidate, GIGA-564, selected due to its reduced checkpoint inhibition, which resulted in superior anti-tumor activity and lower toxicity in murine models compared to commercially available anti-CTLA-4 drugs.
  • We selected GIGA-564 due to its minimal checkpoint inhibition and its ability to deplete intratumoral Tregs in the tumor.
  • GigaGen is advancing transformative antibody drugs for immune deficiency, infectious diseases and checkpoint resistant cancers by leveraging industry-leading, single-cell technologies.
  • In addition, GigaGens lead oncology asset, GIGA-564, is an anti-CTLA-4 monoclonal antibody that has demonstrated improved anti-tumor efficacy in vivo through a unique mechanism of action.

Society for Immunotherapy of Cancer Publishes Clinical Practice Guideline on Immune Checkpoint Inhibitor-related Adverse Events

Retrieved on: 
Wednesday, July 14, 2021
Clinical medicine, Medicine, Cancer, Immune system, Cancer immunotherapy, Antineoplastic drugs, Checkpoint inhibitor, Immune checkpoint, Chemotherapy, Head and neck cancer, Melanoma, PD-1 and PD-L1 inhibitors

ICIs are treatments that unleash the immune system against cancer, but the same mechanisms that underpin their effective anti-tumor properties may cause unique toxicities, specifically immune-related adverse events (irAEs).

Key Points: 
  • ICIs are treatments that unleash the immune system against cancer, but the same mechanisms that underpin their effective anti-tumor properties may cause unique toxicities, specifically immune-related adverse events (irAEs).
  • "I am pleased to share in the excitement of SITC's long-awaited clinical practice guideline on immune checkpoint inhibitor-related adverse events."
  • SITC has published CPGs for acute leukemia , bladder carcinoma, cutaneous melanoma , head and neck squamous cell carcinoma , immune checkpoint inhibitor-related adverse events , immune effector cell-related adverse events , lymphoma , multiple myeloma, non-small cell lung cancer , prostate cancer and renal cell carcinoma.
  • SITC thanks the American Society of Transplantation and Cellular Therapy (ASTCT) and all participating organizations for providing representatives to serve on SITC's Immune Checkpoint Inhibitor-Related Adverse Events Expert Panel and for their efforts in developing this clinical practice guideline.

City of Hope and Osel Announce Exclusive License for Intellectual Property on the Use of Live Biotherapeutic Product CBM588 for Oncology Therapeutic Applications

Retrieved on: 
Wednesday, July 14, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Cancer treatments, Clinical medicine, Bristol-Myers Squibb, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Ipilimumab, Nivolumab, Renal cell carcinoma, Pembrolizumab, Atezolizumab, Osel Inc., City of Hope, Miyarisan, OSEL INC., CITY OF HOPE, MIYARISAN

The experimental treatment was evaluated in a City of Hope investigator-initiated Phase 1b trial.

Key Points: 
  • The experimental treatment was evaluated in a City of Hope investigator-initiated Phase 1b trial.
  • 4513 titled First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM588 in patients with metastatic renal cell carcinoma is available here .
  • We look forward to working with City of Hope to further investigate how CBM588 can improve the lives of cancer patients.
  • Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy .

Sesen Bio Announces Productive Late-Cycle Meeting with the FDA for Vicineum™

Retrieved on: 
Wednesday, July 14, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Clinical medicine, Medicine, Cancer, Cancer immunotherapy, Immune system, Oncology, Cancer treatments, Antineoplastic drugs, Checkpoint inhibitor, Chemotherapy, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

We are very pleased with the outcome of the Late-Cycle Meeting and continue to feel encouraged by the level of engagement from the FDA in our ongoing discussions regarding the BLA for Vicineum, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.

Key Points: 
  • We are very pleased with the outcome of the Late-Cycle Meeting and continue to feel encouraged by the level of engagement from the FDA in our ongoing discussions regarding the BLA for Vicineum, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.
  • Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on our Company.

BriaCell Phase I/IIa Clinical Trial Combination Study in Advanced Breast Cancer Patients Open for Enrollment

Retrieved on: 
Wednesday, July 14, 2021
Cancer treatments, Clinical medicine, Chemical compounds, Epacadostat, Oxadiazoles, Incyte, Indoleamine 2,3-dioxygenase, Cancer immunotherapy, Antineoplastic drugs, Breakthrough therapy, Pembrolizumab

The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.

Key Points: 
  • The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.
  • The BriaCell and Incyte clinical program is a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates.
  • Under the agreement, Incyte is providing compounds from its development portfolio, including retifanlimab, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with Bria-IMT, in advanced breast cancer patients.
  • BriaCell and Incyte had previously treated two patients under this Phase I/IIa combination study subsequent to the corporate collaboration commencement in April 2019 .

Cellectar Announces a Co-Development and Commercialization Collaboration with LegoChemBio for New Small Molecule Phospholipid Drug Conjugates (PDCs)

Retrieved on: 
Monday, July 12, 2021
Antineoplastic drugs, Drugs, Targeted therapy, Medicine, Health care

Under the agreement, the two companies have the option to jointly develop three new small molecule PDCs utilizing Cellectars proprietary drug targeting platform, phospholipid ether (PLE) technology and LegoChemBios proprietary drug conjugate linker-toxin platform.

Key Points: 
  • Under the agreement, the two companies have the option to jointly develop three new small molecule PDCs utilizing Cellectars proprietary drug targeting platform, phospholipid ether (PLE) technology and LegoChemBios proprietary drug conjugate linker-toxin platform.
  • The co-development option is exercisable at defined points with either party allowed to acquire full global commercialization rights.
  • The parties have further agreed to focus development of the drug candidates on solid tumors with significant unmet medical need and potential for accelerated regulatory pathways.
  • This partnership reflects the shared commitment of LegoChemBio and Cellectar to rapidly provide novel targeted therapies to patients with difficult to treat cancers.

AVEO Oncology to Host Key Opinion Leader Webinar on FOTIVDA® (tivozanib) for Relapsed or Refractory Renal Cell Carcinoma

Retrieved on: 
Thursday, July 8, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer treatments, Clinical medicine, Chemical compounds, Kidney cancer, Antineoplastic drugs, Renal cell carcinoma, Orphan drugs, Tivozanib, P110δ, Phosphoinositide 3-kinase inhibitor, FOTIVDA® (tivozanib), AVEO Pharmaceuticals, Inc., FOTIVDA® (TIVOZANIB), AVEO PHARMACEUTICALS, INC.

AVEO's management team will provide a brief company overview and discuss the market opportunity and launch strategy for FOTIVDA.

Key Points: 
  • AVEO's management team will provide a brief company overview and discuss the market opportunity and launch strategy for FOTIVDA.
  • AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
  • FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.
  • FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

DESTINY-Gastric04 Head-to-Head Phase 3 Trial of ENHERTU® Initiated in Patients with HER2 Positive Advanced Gastric Cancer

Retrieved on: 
Thursday, July 8, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Cancer treatments, Drugs, Breakthrough therapy, Antibody-drug conjugates, Daiichi Sankyo, Trastuzumab deruxtecan, Antineoplastic drugs, HER2/neu, Trastuzumab, Breast cancer, Trastuzumab emtansine, DESTINY-Gastric04, HER2 Positive Gastric Cancer, ENHERTU, the ENHERTU Clinical Development Program, Daiichi Sankyo in Oncology, DESTINY-GASTRIC04, HER2 POSITIVE GASTRIC CANCER, ENHERTU, THE ENHERTU CLINICAL DEVELOPMENT PROGRAM, DAIICHI SANKYO IN ONCOLOGY

Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

Key Points: 
  • Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients.
  • In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients.
  • The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01.