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:

Soft Tissue Sarcoma (STS), including Gastrointestinal Stromal Tumor (GIST)

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

Areas of interest based on referenced literature:

• Management and treatment of STS, including GIST
• Role of NTRK gene fusion and impact of TRK gene fusion/TRK testing in STS treatment algorithms
  • 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 in STS treatment algorithms
• Prevention and management of adverse events

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 STS, including GIST

1. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Soft Tissue Sarcoma. Version 4.2019 – September 12, 2019 (link)
2. Caram MV, Schuetze SM. Advanced or metastatic gastrointestinal stromal tumors: systemic treatment options. J Surg Oncol. 2011 Dec;104(8):888-95. (link)

Tyrosine Kinase Inhibitors in STS treatment algorithms

1. Kim EJ and Zalupski MM. Systemic therapy for advanced gastrointestinal stromal tumors: Beyond imatinib. J. Surg. Oncol, 2011 Dec 104 (8): 901-906 (link)
2. George S, Wang Q, Heinrich M, et al. Efficacy and Safety of Regorafenib in Patients with metastatic and/or Unresectable GI Stromal Tumor After Failure of Imatinib and Sunitinib: A Multicenter Phase II Trial. JCO. 2012 Jul 30 (19): 2401-2407 (link)
3. Demetri G, Reichardt P, Kang YK, et al. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib (GRID): an international, multicenter, randomized, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):295-302 (link)
4. Ben-Ami E et al. Long-term follow-up results of the multicenter phase II trial of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of standard tyrosine kinase inhibitor therapy. Ann Oncol. 2016 Sep;27(9):1794-9 (link)
5. Call, JW et al. Survival in advanced GIST has improved over time and correlates with increased access to post-imatinib tyrosine kinase inhibitors: results from Life Raft Group Registry. Clin Sarcoma Res. 2019 Apr 2;9:4. (link)
6. Mir O, Bradodwica T, Italiano, A, et al. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomized, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol 2016; 17:1732-42 (link)
7. Riedel RF, Ballman KV, Lu Y, et al. A randomized, double-blind, placebo-controlled, Phase II study of regorafenib vs placebo in advanced/metastatic, treatment-refractory liposarcoma: results from the SARC04 study. J Clin Oncol 36, 2018 (suppl; abstr 11505). (link)
8. Gounder MM, Mahoney, MR, Van Tine, BA, et al. Phase III, randomized, double blind, placebo-controlled trial of sorafenib in desmoid tumors (Alliance A091105). J Clin Oncol 36, 2018 (suppl; abstr 11500). (link)
9. Penel, N et al. Prior exposure to pazopanib (PAZ) did not reduce efficacy of regorafenib (REG) in non-adipocytic soft tissue sarcoma patients (pts). Annals of Oncology 30(5), October 2019.(link)
10. Penel, N et al. EREMISS: Efficacy of regorafenib (REG) as maintenance therapy in non-adipocytic soft tissue sarcomas (STS) having received 1st-line doxorubicin-based chemotherapy (Doxo-CT). Annals of Oncology 30(5), October 2019. (link)
11. Duffaud, F et al. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019 Jan;20(1):120-133. (link)
12. Davis, LE et al. Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma. J Clin Oncol. 2019 Jun 1;37(16):1424-1431. (link)
13. Pan, PJ et al. Protein Kinase B and Extracellular Signal-Regulated Kinase Inactivation is Associated with Regorafenib-Induced Inhibition of Osteosarcoma Progression In Vitro and In Vivo. J Clin Med. 2019 Jun 24;8(6). (link)
14. Liu, Jie et al. “Rechallenge with Multi-Targeted Tyrosine Kinase Inhibitors in Patients with Advanced Soft Tissue Sarcoma: A Single-Center Experience.” Cancer management and research vol. 13 2595-2601. 18 Mar. 2021, doi:10.2147/CMAR.S300430
15. Wilding, Christopher P et al. “The landscape of tyrosine kinase inhibitors in sarcomas: looking beyond pazopanib.” Expert review of anticancer therapy vol. 19,11 (2019): 971-991. doi:10.1080/14737140.2019.1686979
16. Just, Marissa A et al. “Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.” Pediatric blood & cancer vol. 68,8 (2021): e29084. doi:10.1002/pbc.29084
17. Frezza, Anna Maria et al. “Systemic treatment in advanced soft tissue sarcoma: what is standard, what is new.” BMC medicine vol. 15,1 109. 2 Jun. 2017, doi:10.1186/s12916-017-0872-y
18. Blay, Jean-Yves et al. “Gastrointestinal stromal tumours.” Nature reviews. Disease primers vol. 7,1 22. 18 Mar. 2021, doi:10.1038/s41572-021-00254-5
19. Kelly, Ciara M et al. “The management of metastatic GIST: current standard and investigational therapeutics.” Journal of hematology & oncology vol. 14,1 2. 5 Jan. 2021, doi:10.1186/s13045-020-01026-6
20. Brodowicz T, Mir O, Wallet J, et al. Efficacy and safety of regorafenib compared to placebo and to post-cross-over regorafenib in advanced non-adipocytic soft tissue sarcoma. Eur J Cancer. 2018;99:28-36.
21. Attia S, Bolejack V, Ganjoo KN, et al. A phase II trial of regorafenib (REGO) in patients (pts) with advanced Ewing sarcoma and related tumors (EWS) of soft tissue and bone: SARC024 trial results. J Clin Oncol. 2017;35(15 Suppl):11005
22. Agulnik M, Robinson SI, Okuno SH, et al. Multicenter, open-label phase II study of daily oral regorafenib for chemotherapy-refractory, metastatic and locally advanced angiosarcoma. J Clin Oncol. 2020;38(15 Suppl):11561.
23. Marrari A, Bertuzzi A, Bozzarelli S, et al. Activity of regorafenib in advanced pretreated soft tissue sarcoma. Medicine. 2020;99(26):e20719.
24. Duffaud F, Blay J-Y, Italiano A, et al. Results of the randomized, placebo (PL)-controlled phase II study evaluating the efficacy and safety of regorafenib (REG) in patients (pts) with locally advanced (LA) or metastatic relapsed chondrosarcoma (CS), on behalf of the French Sarcoma Group (FSG) and UNICANCER. Ann Oncol. 2019;30:v926-v927.
25. Duffaud F, Blay JY, Mir O, et al. LBA68 Results of the randomized, placebo (PL)-controlled phase II study evaluating the efficacy and safety of regorafenib (REG) in patients (pts) with metastatic relapsed Ewing sarcoma (ES), on behalf of the French Sarcoma Group (FSG) and UNICANCER. Ann Oncol. 2020;31:S1199.

Prevention and management of adverse events due to TKIs

1. 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)

   Diagnosis, treatment and management of TRK fusion cancer

2. 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)
3. Khotskaya YB, Holla VR, Farago AF, et al. Targeting TRK family protein in cancer. Pharmacol Ther 2017 (173), 58-66. (link)
4. 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)
5. Cocco, E et al. NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol. 2018 Dec;15(12):731-747. (link)
6. 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)
7. 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)
8. 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)
9. 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)
10. 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)
11. Albert, CM. et al. Larotrectinib in pediatric patients with TRK fusion sarcomas: Updated efficacy and safety. CTOS 2021 Presentation
12. Kummar, S et al. Larotrectinib in adult patients with TRK fusion sarcomas: Updated efficacy and safety. CTOS 2021 Presentation