Lung & Pancreatic cancer Patient Knowledge of Research
- Terri Conneran KRAS Kickers
- May 7
- 5 min read
Survival Benefit In PDAC & NSCLC
Patients with advanced non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) often face limited treatment options, especially when standard therapies fail.
Recent clinical trials of a novel viral-based therapy, CAN-2409, has demonstrated survival benefits in these hard-to-treat cancers.
What Is CAN-2409?
CAN-2409 is an investigational, off-the-shelf viral immunotherapy developed by Candel Therapeutics. It involves:
CAN-2409: A replication-defective adenovirus delivering the herpes simplex virus thymidine kinase (HSV-tk) gene directly into tumors.
Valacyclovir: An antiviral prodrug that, when activated by HSV-tk, induces tumor cell death and stimulates an immune response.
This combination aims to convert the tumor into a vaccine-like entity, promoting systemic anti-tumor immunity.
CAN-2409 in Non-Small Cell Lung Cancer (NSCLC)
Patient Profile: Advanced NSCLC patients without EGFR or ALK mutations who have progressed after immunotherapy. This can include people with a KRAS mutation.
Key Findings:
Median Overall Survival (mOS): 24.5 months with CAN-2409 plus valacyclovir, compared to historical averages of 10–12 months with chemotherapy.
Two-Year Survival Rate: Approximately 37% of patients were alive two years post-treatment.
Best Outcomes: Observed in patients with nonsquamous NSCLC.
Safety Profile:
Mostly mild to moderate side effects: fatigue, fever, and injection site reactions.
Few serious adverse events reported.
CAN-2409 in Pancreatic Ductal Adenocarcinoma (PDAC)
Patient Profile: Patients with borderline resectable or locally advanced non-metastatic PDAC.
Key Findings from Phase 2 Trial (PaTK02):
Median Overall Survival: 31.4 months with CAN-2409 plus valacyclovir and standard chemoradiation, versus 12.5 months with standard treatment alone.
Long-Term Survivors: Three out of seven patients treated with CAN-2409 were alive at data cutoff, with survival times of 66.0, 63.6, and 35.8 months.
Immune Activation: Increased infiltration of cytotoxic T cells and pro-inflammatory cytokines observed in tumor microenvironment.
Regulatory Designations:
Fast Track Designation: Granted by the FDA in December 2023.
Orphan Drug Designation: Granted by the FDA in April 2024.
Safety Profile:
Favorable tolerability with no dose-limiting toxicities or cases of pancreatitis reported.
Sources:
Why This Matters
CAN-2409 represents a advancement in the treatment of both NSCLC and PDAC, particularly for patients who have limited options after standard therapies fail. By harnessing the body’s immune system to target and destroy cancer cells, CAN-2409 offers a novel approach that could significantly improve survival outcomes.
Looking Ahead
Candel Therapeutics plans to initiate larger, late-stage randomized controlled trials to further evaluate the efficacy and safety of CAN-2409 in both NSCLC and PDAC. These studies aim to confirm the encouraging results observed in earlier trials and potentially pave the way for regulatory approval.
Next Steps:
While these results are encouraging, further studies are needed to confirm the benefits and determine the best if there is a way to integrate this therapy into standard cancer care.
CAN-2409Pancreatic Cancer* Active not Recruiting!
Borderline Resectable Pancreatic Adenocarcinoma, Fast Track Designation (FDA)
Principal Investigator: Dr. Mark Bloomston, MD
Dr. Mark Bloomston, MD, FACS
Official Title: Medical Director, GI Cancer Service
Affiliation: South Florida Surgical Oncology
Additional Roles:
Surgical Oncologist at GenesisCare
Former Associate Professor and Director of the GI Cancer Service Line at Ohio State University
Role: Dr. Bloomston oversees the Phase 2 PaTK02 trial, which assesses the safety and efficacy of CAN-2409 in combination with valacyclovir and standard chemoradiation in patients with borderline resectable or locally advanced non-metastatic PD
Pancreatic Ductal Adenocarcinoma (PDAC) – Trial NCT02446093
SITC 2023 Presentation: CAN-2409 in Pancreatic Cancer
Abstract Number: 653
Title: Neoadjuvant CAN-2409 + Prodrug Plus Chemoradiation for Borderline Resectable or Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma (PDAC)
Presented at: SITC 2023 Annual Meeting
CAN-2409 Lung Cancer Active not Recruiting!
NSCLC + PD-1/PD-(L)1, Fast Track Designation (FDA) Phase II
1. Non-Small Cell Lung Cancer (NSCLC) – Trial NCT04495153
Principal Investigator: Dr. Charu Aggarwal, MD, MPH
1. Dr. Charu Aggarwal, MD, MPH, FASCO
Official Title: Leslye M. Heisler Associate Professor for Lung Cancer Excellence
Affiliation: Perelman School of Medicine, University of Pennsylvania
Additional Roles:
Director, Program in Precision Oncology Innovation, Penn Center for Cancer Care Innovation (PC3I)
Physician Leader, Airways Malignancies Clinical Research, Abramson Cancer Center
Role: Dr. Aggarwal leads the Phase 2a LuTK02 trial, evaluating the efficacy of CAN-2409 combined with valacyclovir in patients with stage III/IV NSCLC who have shown inadequate responses to immune checkpoint inhibitors.
https://candeltx.com/wp-content/uploads/news/LuTK02_ASCO_Poster_final_05_22_2024.pdf
Sources & References
1. ASCO 2024 Abstract: Phase 2a Trial Results
Source: Journal of Clinical Oncology (JCO)
Summary: This abstract presents the outcomes of a Phase 2a trial evaluating CAN-2409 combined with valacyclovir in patients with stage III/IV NSCLC who had an inadequate response to immune checkpoint inhibitors (ICIs). The study reports a median overall survival (mOS) of 24.5 months in the per-protocol population.
Link:
2. Candel Therapeutics Press Release: Positive Final Survival Data
Source: Candel Therapeutics
Summary: Candel Therapeutics announced positive final survival data from the Phase 2a trial, highlighting a mOS of 24.5 months in patients treated with CAN-2409 plus valacyclovir. The therapy was well-tolerated, with most adverse events being mild to moderate.
Link:
3. Healio News Article: Viral Immunotherapy Shows Survival Benefit
Source: Healio
Summary: This article discusses the significant survival benefit observed with CAN-2409 plus valacyclovir in advanced NSCLC patients who had inadequate responses to ICIs. The therapy nearly doubled survival compared to standard chemotherapy, with patients exhibiting nonsquamous histology deriving greater benefit.
Link:
4. Cancer Network Report: Immune Responses in Stage III/IV NSCLC
Source: Cancer Network
Summary: The report covers the immune responses elicited by the CAN-2409 and valacyclovir combination in stage III/IV NSCLC patients. It notes a median overall survival of 22.0 months and highlights the therapy’s ability to induce systemic antitumor activity, including abscopal effects.
Link:
5. OncLive Article: Favorable Tolerability and Immune Responses
Source: OncLive
Summary: This article emphasizes the favorable tolerability of the CAN-2409 and valacyclovir combination, with most treatment-related adverse events being grade 1 or 2. It also discusses the immune responses observed, including increased circulating T-helper and cytotoxic T cells.
Link:
6. Wall Street Journal Coverage: Candel Therapeutics’ Stock Surge
Source: The Wall Street Journal
Summary: Following the release of positive trial results for CAN-2409 in advanced NSCLC, Candel Therapeutics’ shares surged by 39%. The article provides an overview of the trial outcomes and the therapy’s potential impact on treatment paradigms.
Link:
Non-Small Cell Lung Cancer (NSCLC)
Trial Title: CAN-2409 Plus Valacyclovir With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients
ClinicalTrials.gov Identifier: NCT04495153
Phase: Phase 2
Study Design: Open-label trial evaluating the addition of CAN-2409 and valacyclovir to standard immune checkpoint inhibitors in patients with stage III/IV NSCLC who have shown inadequate response to first-line immunotherapy.
Sponsor: Candel Therapeutics
Reference: ASCO Abstract: JCO.2024.42.16_suppl.8634
Pancreatic Ductal Adenocarcinoma (PDAC)
Trial Title: Neoadjuvant CAN-2409 in Combination With Chemoradiation or SBRT for Borderline Resectable Pancreatic Adenocarcinoma (PaTK02)
ClinicalTrials.gov Identifier: NCT02446093
Phase: Phase 2
Study Design: Randomized, open-label trial assessing the safety and efficacy of CAN-2409 plus valacyclovir in combination with standard chemoradiation and surgery in patients with borderline resectable or locally advanced non-metastatic PDAC.
Sponsor: Candel Therapeutics
Reference: OncLive Article
These trials are pivotal in evaluating the potential of CAN-2409 as a therapeutic option for patients with advanced NSCLC and PDAC, particularly those who have limited treatment alternatives.
Disclaimer:
This information is provided for educational purposes only this is not an endorsement, and does not constitute medical advice.
Clinical trials are research studies and may not be appropriate for everyone. Participation involves risks and benefits that should be carefully discussed with your healthcare provider.
KRAS Kickers is a patient-led nonprofit organization that shares publicly available research to empower patients and caregivers. We do not endorse specific treatments or clinical trial participation without the guidance of a licensed medical professional.