FOLFOX

Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer

Retrieved on: 
Monday, March 18, 2024

The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.

Key Points: 
  • The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.
  • Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy).
  • While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC.
  • “We believe this randomized study could establish a new standard of MRD-guided care in stage II colorectal cancer, potentially improving treatment decisions for thousands of patients.”
    Natera has joined the study in progress.

Caris Life Sciences to Showcase Research Highlighting the Clinical Value of Comprehensive Molecular Profiling at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Thursday, March 28, 2024

IRVING, Texas, March 28, 2024 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present 10 studies across eight tumor types at the 2024 American Association for Cancer Research (AACR) Annual Meeting on April 5-10, 2024, in San Diego, CA, at Booth Number 1105. Caris President, David Spetzler, MS, PhD, MBA, will lead an AACR Scientist ↔ Survivor Program® Special Session titled, "Very Early Cancer Detection Assays: The Future or Fantasy," on Tuesday, April 9, from 1:00 – 1:45 PM.

Key Points: 
  • Tissue-specific thresholds and microenvironment correlates of tumor mutation burden associated with immunotherapy benefit and prognosis in microsatellite stable cancers.
  • (Poster Number: 7037/4)
    Poster and abstract summaries highlighting the Caris research presented at AACR 2024 will be available onsite at Caris' Booth (# 1105).
  • The POA includes 91 cancer centers, academic institutions, research consortia and healthcare systems, including 43 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research.
  • POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

Cardiff Oncology Announces First Patient Dosed in Randomized First-line RAS-mutated Metastatic Colorectal Cancer Trial (CRDF-004)

Retrieved on: 
Thursday, February 29, 2024

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the first patient was dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer (mCRC). The trial, whose clinical execution is being conducted by Pfizer Ignite, Pfizer’s new end-to-end service for biotech companies, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard-of-care (SoC) vs. SoC alone.

Key Points: 
  • “Today’s announcement represents an important milestone for Cardiff Oncology and for patients with RAS-mutated mCRC, who have had no new therapies approved in almost 20 years,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology.
  • We are especially pleased with the opportunity to leverage Pfizer Ignite’s execution capabilities to advance the development of onvansertib.
  • Contingent upon the results of CRDF-004, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
  • Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024.

MiNK’s AgenT-797 Offers New Hope in Overcoming ICI Resistance in PD-1 Refractory Gastric Cancer - Published in Oncogene

Retrieved on: 
Tuesday, January 30, 2024

“Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors.

Key Points: 
  • “Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors.
  • The activity, tolerability, and ease of off-the-shelf administration of iNKT-based cell therapies position them as an attractive approach for overcoming cancer resistance.”
    Gastric cancer, the fifth most common malignancy globally, is incurable with only 12% responsive to ICIs1,2.
  • This phase study (NCT05108623) was designed to evaluate agenT-797, an unmodified iNKT cell therapy, in solid tumors refractory to ICIs.
  • Kono K, Nakajima S, Mimura K. Current status of immune checkpoint inhibitors for gastric cancer.

Bexion Pharmaceuticals, Inc. Announces Poster Presentation at ASCO GI 2024

Retrieved on: 
Tuesday, January 16, 2024

COVINGTON, Ky., Jan. 16, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), today announced a Trials in Progress poster presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), being held January 18-20, 2024, in San Francisco, CA.

Key Points: 
  • COVINGTON, Ky., Jan. 16, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), today announced a Trials in Progress poster presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), being held January 18-20, 2024, in San Francisco, CA.
  • Poster details are included below.
  • "We are excited to present our ongoing trial of BXQ-350 in mCRC during the 2024 ASCO GI Symposium" said Scott Shively, CEO and President of Bexion Pharmaceuticals.
  • "BXQ-350 in combination with FOLFOX and bevacizumab offers a unique opportunity to improve outcomes for 1st line patients with mCRC.

Adagene Presents Data Demonstrating the Best-in-Class Therapeutic Index for Masked Anti-CTLA-4 SAFEbody® ADG126 at SITC 2023

Retrieved on: 
Friday, November 3, 2023

SAN DIEGO and SUZHOU, China, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today presented new data on its masked, anti-CTLA-4 SAFEbody ADG126 at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting taking place in San Diego. The poster presentation, Optimal Dose Selection of ADG126 (Masked Anti-CTLA-4 SAFEbody®) with Significantly Widened Therapeutic Index Compared to Ipilimumab in Combination with anti-PD-1 Antibodies Informed by QSP Modeling, is available on the company’s website.

Key Points: 
  • The poster presentation, Optimal Dose Selection of ADG126 (Masked Anti-CTLA-4 SAFEbody®) with Significantly Widened Therapeutic Index Compared to Ipilimumab in Combination with anti-PD-1 Antibodies Informed by QSP Modeling , is available on the company’s website.
  • The data, which integrate clinical results with physiologically based pharmacokinetic and quantitative systems pharmacology modeling, demonstrated that Adagene’s lead SAFEbody candidate, ADG126, is effective at targeting CTLA-4 within the tumor microenvironment (TME).
  • ADG126 SAFEbody is the most advanced clinical stage anti-CTLA-4 candidate integrating masking technology and Treg depletion for superior safety and efficacy profiles.
  • A phase 2 dose expansion cohort is ongoing to evaluate ADG126 plus pembrolizumab in patients with MSS CRC without liver metastases.

Arcus Biosciences to Present Data from Ongoing EDGE-Gastric Study at ASCO Plenary and to Report Third-Quarter Financial Results on November 7

Retrieved on: 
Tuesday, October 17, 2023

Cohort A1 evaluates the combination of domvanalimab plus zimberelimab and chemotherapy given as an initial treatment in approximately 40 patients.

Key Points: 
  • Cohort A1 evaluates the combination of domvanalimab plus zimberelimab and chemotherapy given as an initial treatment in approximately 40 patients.
  • The ASCO Monthly Plenary Series is a virtual forum for presentation and discussion of the latest cancer research.
  • Abstracts accepted for the Monthly Plenary Session are also placed at the ASCO Annual Meeting in June 2024.
  • Following the release, Arcus management will host a conference call to discuss the financial results, EDGE-Gastric results and other pipeline updates.

More Aggressive Treatment Doesn't Impact Quality of Life for Metastatic Colorectal Cancer Patients, According to New Study in JNCCN

Retrieved on: 
Thursday, October 12, 2023

PLYMOUTH MEETING, Pa., Oct. 12, 2023 /PRNewswire/ -- New research in the October 2023 issue of JNCCN—Journal of the National Comprehensive Cancer Network finds that intensive local-regional treatment to remove as much tumor as possible (known as "debulking"), in addition to standard systemic therapy, does not impact overall quality of life significantly for people with metastatic colorectal cancer.

Key Points: 
  • Significant adverse events were reported in 21% of patients in the standard group and 43% of patients who also received tumor debulking.
  • However, there were no statistical or clinically relevant differences according to patient-reported outcomes for overall health-related quality of life or fatigue.
  • "This could mean that the negative impact of complications on quality of life is temporary and eventually balances out with a decrease in tumor-related symptoms after treatment.
  • "Given the considerable amount of complications from local treatment, we had expected to see a bigger impact on overall and persistent quality of life in the experimental group.

Cardiff Oncology Reports Second Quarter 2023 Results and Provides Business Update

Retrieved on: 
Wednesday, August 9, 2023

SAN DIEGO, Aug. 9, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today announced financial results for the second quarter ended June 30, 2023, and provided a business update.

Key Points: 
  • "2023 has been transformative for Cardiff Oncology, highlighted by the advancement of our lead program to the first-line mCRC setting and an expansion of our relationship with Pfizer," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology.
  • Company highlights for the quarter ended June 30, 2023 and resent announcements
    Announced new lead program in mCRC and expanded Pfizer relationship.
  • Contingent upon the results of CRDF-004, Cardiff Oncology will initiate CRDF-005, a Phase 3, randomized trial with registrational intent.
  • As of June 30, 2023, Cardiff Oncology had approximately $89.4 million in cash, cash equivalents, and short-term investments.

New Study in JNCCN Highlights Rapid Adoption of Clinical Research Results into Chemotherapy Prescribing Patterns

Retrieved on: 
Monday, August 7, 2023

PLYMOUTH MEETING, Pa., Aug. 7, 2023 /PRNewswire/ -- New research in the August 2023 issue of JNCCN—Journal of the National Comprehensive Cancer Network evaluates how an important analysis on local-regionally advanced colon cancer adjuvant chemotherapy impacted prescribing patterns. The IDEA collaboration included more than 12,000 patients with Stage III colon cancer across 6 randomized phase 3 trials in a planned pooled analysis, to determine how three or six months of post-surgery chemotherapy—either a combination of capecitabine/oxaliplatin (CAPOX) or fluorouracil/leucovorin/oxaliplatin (FOLFOX)—impacted outcomes.1 The current JNCCN study revealed that after the full publication of IDEA, the percentage of patients treated with CAPOX rose from 14% to 48%. Also, 45.2% of patients were prescribed adjuvant therapy for only three months after IDEA, compared to just 5.6% before.

Key Points: 
  • Also, 45.2% of patients were prescribed adjuvant therapy for only three months after IDEA, compared to just 5.6% before.
  • After publication of IDEA, 45.2% of patients were prescribed adjuvant therapy for only 3 months compared to 5.6% before.
  • "Our study results showed a significant increase in planning for three months of adjuvant chemotherapy after the presentation of IDEA.
  • Complimentary access to " Changes in Prescribing Patterns in Stage III Colon Cancer " is available until November 10, 2023.