Adjuvant therapy

Trilaciclib Increases Pool of Memory T Cells in the Tumor Microenvironment Responsible for Long Term Immune Surveillance and Efficacy

Retrieved on: 
Sunday, June 4, 2023

RESEARCH TRIANGLE PARK, N.C., June 04, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today presented results from 24 patients enrolled in its Phase 2, single arm mechanism of action study of trilaciclib administered as a single agent to patients with early-stage triple-negative breast cancer (TNBC) prior to receiving trilaciclib and neoadjuvant therapy. These results highlight the potential for trilaciclib to enhance long term immune surveillance by increasing T cell function and generation of certain memory T cells and demonstrate gene expression profiles that may be associated with improved clinical outcome. These data support earlier findings from this Phase 2 trial demonstrating an increase in the ratio of CD8+ T cells to regulatory T cells (Tregs); a high ratio of CD8+ T cell to Tregs is predictive of overall survival (OS) and is associated with pathologic complete response (pCR). As expected, high rates of pCR were observed in patients with PD-L1(+) tumors and in patients with inflamed tumor immune microenvironments.

Key Points: 
  • As expected, high rates of pCR were observed in patients with PD-L1(+) tumors and in patients with inflamed tumor immune microenvironments.
  • Data published by G1 and others show that trilaciclib can promote trafficking of immune cells out of the stroma and into the tumor microenvironment via chemokine release, thus leading to an inflamed tumor immune microenvironment status.
  • Trilaciclib was shown to enhance the number and function of CD8+ T cells in the tumor microenvironment.
  • These results help confirm the role of trilaciclib in increasing the pool of functional memory T cells that could contribute to long-term immune surveillance and efficacy, as measured by longer term endpoints like OS.

Oncocyte to Report Second Quarter 2021 Financial Results on Tuesday, August 10

Retrieved on: 
Tuesday, July 27, 2021

The Company will host a conference call on Tuesday, August 10, 2021, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.

Key Points: 
  • The Company will host a conference call on Tuesday, August 10, 2021, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.
  • To access the live webcast, go to the investor relations section on the Companys website, or by clicking here: http://public.viavid.com/index.php?id=145975 .
  • The Companys tests are designed to help provide clarity and confidence to physicians and their patients at every stage of care.
  • DetermaRx identifies early-stage lung cancer patients who are at high risk for cancer recurrence and predicts benefit from adjuvant chemotherapy.

Lumeda Announces Appointment of Jason Pesterfield to Board of Directors

Retrieved on: 
Tuesday, July 20, 2021

ROCKY HILL, Conn., July 20, 2021 /PRNewswire-PRWeb/ -- Lumeda Inc. , a medical technology company advancing Photodynamic Therapy (PDT) as an intraoperative adjuvant treatment for patients during lung cancer surgery, today announced the appointment of Jason Pesterfield to its board of directors.

Key Points: 
  • ROCKY HILL, Conn., July 20, 2021 /PRNewswire-PRWeb/ -- Lumeda Inc. , a medical technology company advancing Photodynamic Therapy (PDT) as an intraoperative adjuvant treatment for patients during lung cancer surgery, today announced the appointment of Jason Pesterfield to its board of directors.
  • "We are excited to have Jason join our board of directors to bring his deep experience in lung cancer surgery and global connections to thoracic surgeons and interventional pulmonologist," said Lumeda CEO, Sandy Zinke.
  • "Jason has significant expertise in developing innovative commercialization strategies to launch new medical technologies in the lung cancer space.
  • "I am excited to be joining the talented Lumeda team to help them introduce this important adjuvant therapy for treating lung cancer," said Pesterfield.

Celsion Reports Data Safety Monitoring Board Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

Retrieved on: 
Monday, July 19, 2021

The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.

Key Points: 
  • The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.
  • NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy.
  • Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.
  • The Company also announced that more than 50% of the projected 110 patients have been enrolled in the OVATION 2 Study.

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

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.

Reven’s Co-Founder Michael Volk Appears on Cheddar News

Retrieved on: 
Friday, July 9, 2021

In this national broadcasted interview, Mr. Volt shared the companys goals to bring their flagship platform drug Rejuveinix (RJX) to market.

Key Points: 
  • In this national broadcasted interview, Mr. Volt shared the companys goals to bring their flagship platform drug Rejuveinix (RJX) to market.
  • Mr. Volk responded We believe we're positioned very well to be a disruptor.
  • We are best at the moment, and where science works for best applied as an adjunct therapy to current standards of care.
  • Some people, the side effects aren't bad enough where, you know, they can still take benefit from it.

Puma Biotechnology Presents Data from the Phase III ExteNET Trial in Early Stage HER2-Positive Breast Cancer Patients at the Virtual 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented results from the Phase III ExteNET trial assessing the impact of neratinib treatment duration on overall survival (OS) in patients with early stage HER2-positive breast cancer at the virtual 2021 ASCO Annual Meeting.

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented results from the Phase III ExteNET trial assessing the impact of neratinib treatment duration on overall survival (OS) in patients with early stage HER2-positive breast cancer at the virtual 2021 ASCO Annual Meeting.
  • ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive early stage breast cancer patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab-based treatment.
  • These descriptive findings suggest that overall survival in patients with early stage HER2-positive breast cancer patients is improved upon completion of neratinib extended adjuvant therapy.
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

Oncocyte Announces Collaboration with Gruppo Oncologico del Nord Ovest to Evaluate Oncocyte’s DetermaIO Test in Colorectal Cancer, the Second Leading Cause of Cancer Mortality Globally

Retrieved on: 
Thursday, June 3, 2021

As a physician treating colorectal cancer, it would be valuable for me to be able to offer immunotherapy to more patients.

Key Points: 
  • As a physician treating colorectal cancer, it would be valuable for me to be able to offer immunotherapy to more patients.
  • GONO Foundation and Dr. Cremolini are highly respected in the world of immune-oncology and the collaboration with Oncocyte is timely and important.
  • Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum.
  • Oncocyte launched DetermaRx, a test that identifies early-stage lung cancer patients who are at high risk for cancer recurrence post-resection, and predicts benefit from adjuvant chemotherapy.

Oncocyte Selected as New “Day One” Launch Site for QIAGEN’s Companion Diagnostics Test to Identify Patients for Amgen’s Newly FDA-Approved Drug LUMAKRAS (Sotorasib) For Advanced Stage Lung Cancer

Retrieved on: 
Tuesday, June 1, 2021

LUMAKRAS (Sotorasib) is approved for patients with KRAS G12C-mutated locally advanced stage or metastatic Non-Small Cell Lung Cancer (NSCLC).

Key Points: 
  • LUMAKRAS (Sotorasib) is approved for patients with KRAS G12C-mutated locally advanced stage or metastatic Non-Small Cell Lung Cancer (NSCLC).
  • NSCLC accounts for approximately 84 percent of the 2.2 million new lung cancer diagnoses each year worldwide, including approximately 236,000 new cases in the U.S.
  • Approximately 80% of patients are diagnosed with advanced stage or metastatic cancer.
  • Oncocyte launched DetermaRx, a test that identifies early-stage lung cancer patients who are at high risk for cancer recurrence post-resection and predicts benefit from adjuvant chemotherapy.

Natera to Present Clinical Data from Largest Prospective MRD-Guided Trial in Colorectal Cancer at the 2021 ASCO Annual Meeting

Retrieved on: 
Thursday, May 20, 2021

"We look forward to continuing our collaboration with Natera and working toward our goal of making this technology the standard of care for cancer patients worldwide.

Key Points: 
  • "We look forward to continuing our collaboration with Natera and working toward our goal of making this technology the standard of care for cancer patients worldwide.
  • "Natera is deeply committed to driving insights and data about colorectal cancer which will play a critical role in helping oncologists accurately treat colorectal cancer patients, particularly when it comes to adjuvant chemotherapy.
  • We look forward to discussing these results with the oncology community at this year\'s ASCO conference.
  • Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California.