Khapzory (levoleucovorin) / Aurobindo, Assertio - LARVOL DELTA

BREAKWATER: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=831 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF

BREAKWATER: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=827 | Active, not recruiting | Sponsor: Pfizer | Trial primary completion date: Jan 2025 ➔ Dec 2025

Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF

In vitro compatibility of admixture solutions of 5-fluorouracil and khapzory (disodium levofolinate) in a single infusion bag. (PubMed, J Oncol Pharm Pract) - "Combining 5-FU and disodium levoleucovorin in admixture IV bags eliminates the risk of catheter occlusion associated with calcium-based levoleucovorin formulations. This approach offers a more favorable operational and safety profile, enhancing convenience for patients and cost-efficiency for institutions."

Journal • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

BREAKWATER: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=816 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) (clinicaltrials.gov) - P3 | N=335 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Oct 2023

Combination therapy • Metastases • Trial completion • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) (clinicaltrials.gov) - P3 | N=335 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Jul 2024 ➔ Mar 2023

Combination therapy • Metastases • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) (clinicaltrials.gov) - P3 | N=335 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2027 ➔ Jul 2024 | Trial primary completion date: Jan 2027 ➔ Jul 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

ASCO GI 2023 NAPOLI-3 Randomized, Open-Label Phase 3 Study: Liposomal Irinotecan + 5-Fluorouracil/Leucovorin + Oxaliplatin (NALIRIFOX) vs. nab-Paclitaxel + Gemcitabine in Treatment-Naïve Patients With mPDAC (VuMedi) - https://www.vumedi.com/video/asco-gi-2023-napoli-3-randomized-open-label-phase-3-study-liposomal-irinotecan-5-fluorouracilleucovo/

Video

Metastatic Colorectal Cancer: Selecting Treatment for Brain Metastases (MedPageToday) - "Elaine is a 36-year-old woman with KRAS/BRAF wild-type HER2-positive de novo metastatic colorectal cancer (ECOG performance status 1; Stage IV). Her first-line treatment included induction with leucovorin, fluorouracil, oxaliplatin, and bevacizumab followed by a non-oxaliplatin-containing maintenance chemotherapy regimen."

Online posting

NAPOLI-3: first-line NALIRIFOX in metastatic pancreatic ductal adenocarcinoma (YouTube) - "Zev Wainberg, MD...presents findings from the Phase III NAPOLI-3 trial (NCT04083235), which compared liposomal irinotecan, oxaliplatin, 5-fluorouracil, and leucovorin (NALIRIFOX) to nab-paclitaxel with gemcitabine in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. Patients receiving NALIRIFOX demonstrated superior overall survival and progression-free survival, providing a promising first-line treatment for a group of patients with limited options. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Gastrointestinal Cancers (GI) Symposium in San Francisco, CA."

Interview • Video

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) (clinicaltrials.gov) - P3 | N=335 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | N=525 ➔ 335

Combination therapy • Enrollment change • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) (clinicaltrials.gov) - P3 | N=525 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER) (clinicaltrials.gov) - P3; N=930; Recruiting; Sponsor: Pfizer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER) (clinicaltrials.gov) - P3; N=930; Not yet recruiting; Sponsor: Pfizer

Clinical • New P3 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

Actively Recruiting Clinical Trials on Colorectal Cancer (THE ASCO POST) - "This Clinical Trials Resource Guide lists actively recruiting trials on colorectal cancer, focusing on novel treatments, combinations of treatments, and testing options to determine which patients may be most likely to benefit from further treatment....Principal Investigator: Frank A. Sinicrope, MD."

Onvansertib Triplet Shows Promise in KRAS-Mutant Metastatic Colorectal Cancer (Targeted Oncology) - "The preliminary results from the study are interesting because this is a phase Ib dose-escalation trial looking at the standard chemotherapy regimen FOLFIRI plus bevacizumab in combination with onvansertib. What we noticed is that when we looked at some of the correlative work, including capturing circulating tumor DNA (ctDNA), which demonstrated a decrease in percentage ofKRAS-mutated circulating tumor DNA. These were the patients that were treated with the investigational agents in combination with chemotherapy and bevacizumab. Not only did we see evidence of radiographic response, but we also saw evidence of a decrease in theirKRAS-mutated ctDNA."

Interview

TIL Density and Tumor Budding Validated as Prognostic Factors for DFS in Stage III CRC (Targeted Oncology) - P=NA, N=1532; "[The study confirmed] that use of Immunoscore in combination with established prognostic factors allows one to more accurately assess prognosis, highlighting the clinical utility of Immunoscore' said Frank A. Sinicrope, MD...in response to the published data....Overall, low TILs, high budding, and the presence of micropapillary features were significantly higher with T stage, N stage, and pMMR. TIL density and tumor budding also appeared to be significantly associated with DFS after adjustments for covariates. The prognostic significance was confirmed in the validation set of the study."

Clinical data • Media quote