CAPOX

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.

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.

Astellas Submits New Drug Application for Zolbetuximab in Japan

Retrieved on: 
Friday, June 9, 2023

TOKYO, June 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.

Key Points: 
  • If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.
  • "Astellas' submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan."
  • The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.
  • The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

Astellas Highlights Continued Delivery of Strong Cancer Portfolio and Pipeline at 2023 ASCO Annual Meeting

Retrieved on: 
Thursday, May 25, 2023

TOKYO, May 25, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research from across its expanding portfolio of approved and investigational cancer therapies during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6. A total of 15 abstracts, covering three approved medicines and one investigational therapy, will be presented underscoring the company's focus on pursuing targeted therapies for hard-to-treat cancers where few therapies exist, including prostate, urothelial, gastric/gastroesophageal junction (GEJ) and head & neck cancers, as well as acute myeloid leukemia (AML).

Key Points: 
  • TOKYO, May 25, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research from across its expanding portfolio of approved and investigational cancer therapies during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6.
  • The first clinical data from the Phase 1 EV-104 study evaluating intravesical administration of enfortumab vedotin, an antibody-drug conjugate developed in partnership with Seagen, in patients with non-muscle invasive bladder cancer.
  • The first clinical data from the Phase 2 EV-202 study evaluating enfortumab vedotin monotherapy in previously treated advanced head & neck cancers.
  • "Additionally, Astellas is pleased to share investigational data at ASCO that demonstrate continued progress for our zolbetuximab clinical development program in locally advanced or metastatic gastric and GEJ cancers, which have limited effective treatment options."

Predicine to Introduce PredicineALERT™ MRD Assay and Present Twelve Posters at AACR 2023 Conference

Retrieved on: 
Friday, April 14, 2023

Long term result and ctDNA correlatives for CAPOX BETR: A multi-center phase II trial of capecitabine, oxaliplatin, bevacizumab and trastuzumab for previously untreated HER2 positive metastatic gastroesophageal adenocarcinoma

Key Points: 
  • Long term result and ctDNA correlatives for CAPOX BETR: A multi-center phase II trial of capecitabine, oxaliplatin, bevacizumab and trastuzumab for previously untreated HER2 positive metastatic gastroesophageal adenocarcinoma
    “Predicine is excited to introduce the next-generation MRD assay, PredicineALERT™,” said Shidong Jia, Founder and global CEO of Predicine.
  • “The PredicineALERT assay represents a methylation-based approach to MRD testing without personalization, minimizing the operational burden from the current tumor-informed personalized MRD assay.
  • In collaboration with our biopharma and academic partners, we are glad to see the analytical and clinical feasibility data utilizing cell-free DNA (cfDNA) to enable global clinical trials, CDx development, and patient testing.”

Claudin18.2, a shining star in gastric cancer, Transcenta's TST001 stands at the global forefront

Retrieved on: 
Wednesday, September 28, 2022

Based on these encouraging data, the TST001 program is further accelerated and Health Authority consultations are being initiated.

Key Points: 
  • Based on these encouraging data, the TST001 program is further accelerated and Health Authority consultations are being initiated.
  • A global phase III clinical program of TST001 (Osemitamab) for the first line treatment of locally advanced or metastatic Claudin18.2 positive G/GEJ cancer is currently being planned.
  • In this study, TST001 also demonstrated a clear dose proportional pharmacokinetic profile, is consistent with those observed with TST001 monotherapy and in US patients.
  • As TST001 data continue to mature, Transcenta progresses TST001 towards phase III trial and has initiated Health authority consultations.

Transcenta Releases Encouraging Interim Safety and Efficacy Data of the TST001 (Osemitamab) and Chemotherapy Combination Expansion Cohort for First Line Claudin18.2 Positive Gastric Cancer at ESMO Congress 2022

Retrieved on: 
Tuesday, September 13, 2022

Based on these encouraging data, the TST001 (Osemitamab) program is further accelerated and Health Authority consultations are being initiated.

Key Points: 
  • Based on these encouraging data, the TST001 (Osemitamab) program is further accelerated and Health Authority consultations are being initiated.
  • A global phase III clinical program of TST001 (Osemitamab) for the first line treatment of locally advanced or metastatic Claudin18.2 positive G/GEJ cancer is currently being planned.
  • These data suggest that TST001 (Osemitamab) in combination with CAPOX as the first line treatment of patients with Claudin18.2 positive G/GEJ cancer is well tolerated and encouraging anti-tumor activities have been observed.
  • "Chemotherapy is still the main treatment of advanced or metastatic G/GEJ cancer, however, it has limited efficacy.

Transcenta to Present Interim Safety and Efficacy Data of the TST001 and Chemotherapy Combination Expansion Cohort for Claudin18.2 Positive First Line Gastric Cancer at ESMO Congress 2022

Retrieved on: 
Thursday, July 28, 2022

TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally.

Key Points: 
  • TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally.
  • TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
  • Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001.
  • TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

Transcenta Releases Phase I Clinical Data of TST001 in Combination with CAPOX as the First Line Treatment of Advanced and Metastatic G/GEJ Cancer at ASCO 2022

Retrieved on: 
Thursday, June 2, 2022

The data showed that TST001 in combination with CAPOX as the first line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities have been observed.

Key Points: 
  • The data showed that TST001 in combination with CAPOX as the first line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities have been observed.
  • The recruitment for the current cohort is ongoing, and the safety and efficacy of the combination of TST001+CAPOX as first line treatment for patients with advanced and metastatic G/GEJ cancer will be further evaluated.
  • We believe that TST001 in combination with chemotherapy could provide a novel option for the treatment of Claudin18.2 positive gastric cancer patients globally."
  • TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

Transcenta to Present Clinical Trial Data of TST001 and MSB0254 at 2022 ASCO Annual Meeting

Retrieved on: 
Friday, April 29, 2022

SUZHOU, China, April 28, 2022 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the abstracts of TST001 and MSB0254 have been accepted by the 2022 annual meeting of American Society of Clinical Oncology ("2022 ASCO Annual Meeting").

Key Points: 
  • SUZHOU, China, April 28, 2022 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the abstracts of TST001 and MSB0254 have been accepted by the 2022 annual meeting of American Society of Clinical Oncology ("2022 ASCO Annual Meeting").
  • The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world's most influential and prominent scientific gathering of the clinical oncology community.
  • This year's ASCO Annual Meeting will take place both online and in-person (McCormick Place; Chicago, IL) on June 37, 2022.
  • Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001.