Bayer Oncology Medical Affairs Department is interested in receiving and reviewing grant applications to support appropriate programs which cover the following area of interest:

Therapeutic Areas/Disease States:

Colorectal Cancer (CRC)

Intended Audience: Oncologists, Surgeons, Pathologists, Community HCPs, Patients/Caregivers

Areas of interest based on referenced literature:

• Management and treatment of metastatic CRC
  • Identification of appropriate treatment for patients with mCRC based on MOA and biomarkers
• Role of NTRK gene fusion and impact of TRK gene fusion/TRK testing in treatment algorithms for local, regional and/or metastatic CRC
  • Treatment and management of TRK fusion cancer
  • Understanding of efficacy and safety profiles of approved TRK inhibitors
• Multi-disciplinary approach to precision medicine
• Role of Tyrosine Kinase Inhibitors (TKIs) in metastatic CRC treatment algorithms
  • Differences in AE profiles of approved agents and prevention and management of adverse events due to TKIs

Proposal Requirements:

All submissions for CE/CME support must be consistent with the ACCME guidelines and contain supporting documents that should include:

• Needs assessment
• Educational design and rationale for selection (where applicable)
• Learning objectives
• Proposed faculty
• Participant recruitment plan (where applicable)
• Outcomes strategy/plan (required on a quarterly basis)
• Detailed budget

Provider Justification:

• Copy of most recent accreditation letter and status
• Sample of other program(s) in similar therapeutic area

Process

Applications/proposals which are submitted and determined to be complete are reviewed monthly. Allow a minimum of 45 days from submission for response.

Acceptance of a Bayer educational grant indicates that you will:

• Reconcile grant funding within 60 days of completion of the educational program
• Permit a Bayer Medical Affairs representative to audit live programs
• Share activity data and outcomes metrics within 30 days of their availability

References

Management and treatment of metastatic CRC

1. American Cancer Society. Colorectal Cancer Facts & Figures 2017-2019. Atlanta: American Cancer Society; 2017. Available at: http://www.cancer.org/. (link)
2. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Colon Cancer (Version 3.2019 – Sep 26, 2019). (link)
3. Cassidy J, Clarke S, Diaz-Rubio E, et al. Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol. 2008;26:2006-2012.(link)
4. Chu E. An update on the current and emerging targeted agents in metastatic colorectal cancer. Clin Colorectal Cancer. 2012 Mar;11(1):1-13. (link)
5. Koopman M, Antonini NF, Douma J, et al. Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial. Lancet. 2007 Jul 14;370(9582): 135-42. (link)
6. Seymour MT, Maughan TS, Ledermann JA, et al. Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet. 2007 Jul 14;370(9582):143-52. (link)
7. Saltz LB, Clarke S, Diaz-Rubio E, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomised phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. (link)
8. Tintelnot, J, Stein, A. Immunotherapy in colorectal cancer: Available clinical evidence, challenges and novel approaches. World J Gastroenterol. 2019 Aug 7;25(29):3920-3928. (link)

   Diagnosis, treatment and management of TRK fusion cancer

9. Hong DS, Bauer TM, Lee JJ et al. Larotrectinib in adult patients with solid tumours: a multi-centre, open-label, phase I dose-escalation study. Ann Oncol. 2019 Feb 1;30(2):325-331. (link)
10. Khotskaya YB, Holla VR, Farago AF, et al. Targeting TRK family protein in cancer. Pharmacol Ther 2017 (173), 58-66. (link)
11. Drilon A, Laetsch TW, Kummar S et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med 2018; 378: 731-9. (link)
12. Cocco, E et al. NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol. 2018 Dec;15(12):731-747. (link)
13. Hyman, DM et al. Durability of response with larotrectinib in adult and paediatric patients with TRK fusion cancer. Annals of Oncology 30 (5), October 2019 (link)
14. Kummar, S et al. Patient-reported outcomes from two global multicenter clinical trials of children and adults with tropomyosin receptor kinase (TRK) fusion cancers receiving larotrectinib. Journal of Clinical Oncology 37, 2019 (suppl; abstr 6602) (link)
15. Cocco, E et al. Colorectal Carcinomas Containing Hypermethylated MLH1 Promoter and Wild-Type BRAF/KRAS Are Enriched for Targetable Kinase Fusions. Cancer Res. 2019 Mar 15;79(6):1047-1053. (link)
16. Ricciuti, B et al. Antitumor activity of larotrectinib in tumors harboring NTRK gene fusions: a short review on the current evidence. Onco Targets Ther. 2019 Apr 30;12:3171-3179 (link)
17. Solomon, JP et al. NTRK fusion detection across multiple assays and 33,997 cases: diagnostic implications and pitfalls. Mod Pathol. 2019 Aug 2. (Epub ahead of print) (link)
18. Wong, D et al. Methods for Identifying Patients with Tropomyosin Receptor Kinase (TRK) Fusion Cancer. Pathol Oncol Res. 2019 Jun 29. (Epub ahead of print) (link)
19. Boni, V et al. Efficacy and safety of larotrectinib in patients with tropomyosin receptor kinase fusion-positive gastrointestinal cancer: An expanded dataset. WCGI 2021 Presentation.

    Role of Tyrosine Kinase Inhibitors (TKIs) in metastatic CRC treatment algorithms

20. Grothey A, Cutsem EV, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013 Jan 26; 381 (9863), p303-312 (link)
21. Li, J et. al. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015 Jun; 16 (6), p619–629. (link)
22. Ducreux, M et al. Regorafenib dose escalations in the prospective, observational CORRELATE study in patients with metastatic colorectal cancer (mCRC). Annals of Oncology 30(4), July 2019 (link)
23. Kennedy A et al. Regorafenib Prior to Selective Internal Radiation Therapy Using 90Y-Resin Microspheres for Refractory Metastatic Colorectal Cancer Liver Metastases: Analysis of Safety, Dosimetry, and Molecular Markers. Frontiers in Oncology 2019 Jul 10;9:624. (link)
24. Hofheinz, R et al. Effect of regorafenib in delaying definitive deterioration in health-related quality of life across three tumor types. Annals of Oncology 30 (4), July 2019 (link)
25. Bekaii-Saab, TS et al. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study. Lancet Oncology 2019 Aug;20(8):1070-1082. (link)
26. Riechelmann, RP et al. Regorafenib in Patients with Antiangiogenic-Naïve and Chemotherapy-Refractory Advanced Colorectal Cancer: Results from a Phase IIb Trial. Oncologist. 2019 Sep;24(9):1180-1187 (link)
27. Fukuoka, S et al. Regorafenib plus nivolumab in patients with advanced gastric (GC) or colorectal cancer (CRC): An open-label, dose-finding, and dose-expansion phase 1b trial (REGONIVO, EPOC1603). J Clin Onc 2019 37:15_suppl, 2522-2522. (link)
28. Ducreux, M et al. Regorafenib dose escalations in the prospective, observational CORRELATE study in patients with metastatic colorectal cancer (mCRC). Annals of Oncology Volume 30, Issue Supplement_4, July 2019. (link)
29. Boni, V et al. Efficacy and safety of larotrectinib in patients with tropomyosin receptor kinase fusion-positive gastrointestinal cancer: An expanded dataset. WCGI 2021 Presentation.

    Prevention and management of adverse events due to TKIs

30. Grothey, A et al. Exploration of efficacious alternative regorafenib regimens to manage hand-foot-skin-reaction (HFSR); Annals of Oncology 30 (5), October 2019 (link)
31. Sato, J et al. Adherence to a topical moisturizing preparation for regorafenib-related hand-foot skin reaction. J Oncol Pharm Pract. 2019 May 19:1078155219849275. (link)