Bayer: Science For A Better Life

United States of America

Oncology Information for Grant Submissions


Bayer has been made aware that a statement in the briefing document is causing confusion, which we would like to address. Regarding Copanlisib, the FDA briefing document states “Voluntary withdrawal of NDA based on CHRONOS-3 (12/2021)” Table 1, page 13. Based on questions we have received, it seems that this statement is being interpreted by some physicians to mean that Copanlisib was withdrawn from the market. We would like to clarify that while Bayer withdrew the supplemental NDA for CHRONOS-3, the authorization for Copanlisib, based on CHRONOS-1, remains in place (treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies). (link)

BHC 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:

Non-Hodgkin Lymphoma (NHL)

Intended Audience: Hematologic Oncologists, Medical Oncologists, Nurses

Areas of interest based on referenced literature:

  • Treatment landscape in relapsed/refractory indolent NHL (second line and beyond)
    • Unmet need in Follicular lymphoma and management of high-risk patients (i.e. POD24)
    • Unmet need in Marginal Zone Lymphoma 
  • Integration of PI3K inhibition in treatment algorithms in relapsed/refractory indolent NHL (second line and beyond)
    • Role of PI3K and synergistic pathways in NHL (i.e. follicular lymphoma, marginal zone lymphoma)
    • Emerging data for PI3K inhibitors in relapsed/refractory NHL: mono-therapy and combination therapy
  • Adverse event management and safety considerations of PI3K inhibitors based on patient factors and comorbidities
    • Identification of proper patient population
    • Patient compliance
    • Long term safety

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


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 BHC 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 upon the quarterly requirement or more if available


Management and treatment of indolent NHL

  1. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: B-cell Lymphomas. Version 3.2022 – April 25, 2022  (link)
  2. Welaya, K, Casulo, C2. Follicular Lymphoma: Redefining Prognosis, Current Treatment Options, and Unmet Needs. Hematol Oncol Clin North Am. 2019 Aug;33(4):627-638. (link)
  3. Matasar, MJ et al. Follicular Lymphoma: Recent and Emerging Therapies, Treatment Strategies, and Remaining Unmet Needs. Oncologist. 2019 Jul 25. pii: theoncologist.2019-0138. (link)

    Role of PI3K inhibition in in hematologic malignancies

  1. von Keudell, G, Moskowitz, AJ. The Role of PI3K Inhibition in Lymphoid Malignancies. Curr Hematol Malig Rep. 2019 Oct;14(5):405-413. (link)
  2. Georgios Pongas, et al. PI3K signaling pathway in normal B cells and indolent B-cell malignancies. Seminars in Oncology 2016: 43, 647–654. (link)
  3. Elias Jabbour, et al. Targeting the phosphoinositide 3-kinase pathway in hematologic malignancies. Haematologica 2014: 99, 7-18. ((link)
  4. Kevin Courtney, et al. The PI3K Pathway As Drug Target in Human Cancer. J Clin Onc, 2010: 28. 1075-1083. (link)
  5. Faruk Ramadani, et al. The PI3K Isoforms p110α and p110δ are Essential for Pre-B Cell Receptor Signaling and B Cell Development. Science Signaling 2010: 3(134), pp. ra60. (link)

    PI3K Inhibitors in NHL – Monotherapy

  1. Martin Dreyling, et al. Long-term safety and efficacy of the PI3K inhibitor copanlisib in patients with relapsed or refractory indolent lymphoma: 2-year follow-up of the CHRONOS-1 study. Am J Hematol. 2020 Apr; 95(4):362-371. (link)
  2. Leppä, S et al. Long-term follow-up of patients with relapsed or refractory follicular lymphoma treated with copanlisib. J Clin Onc 37(15), 2019: 7553-7553 (link)
  3. Armando Santoro, et al. Outcomes for Patients with High-Risk Relapsed or Refractory Indolent B-Cell Lymphoma Treated with Copanlisib in the CHRONOS-1 Study. Blood. 2018:395 (ASH abstract) (link)
  4. Panayiotis Panayiotidis, et al. Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma. Blood Adv. 2021 Feb 9;5(3):823-828. (link)
  5. Pier Luigi Zinzani, et al. Outcomes for Patients with Pre-Existing Diabetes or Hypertension Treated with Copanlisib from the CHRONOS-1 Study in Patients with Relapsed or Refractory Indolent B-Cell Lymphoma. Blood. 2018: 1613 (ASH abstract) (link)
  6. Martin Dreyling, et al. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. (link)
  7. Martin Dreyling, et al. Phosphatidylinositol 3-Kinase Inhibition by Copanlisib in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2017 Dec 10;35(35):3898-3905. (link)
  8. Javier Munoz, et al. Copanlisib for the Treatment of Malignant Lymphoma: Clinical Experience and Future Perspectives. Target Oncol. 2021 May;16(3):295-308. (link)
  9. Ayushi F Chauhan, et al. Copanlisib in the Treatment of Relapsed Follicular Lymphoma: Utility and Experience from the Clinic. Cancer Manag Res. 2021 Jan 25;13:677-692. (link)
  10. Eltantawy, A et al. Copanlisib: An Intravenous Phosphatidylinositol 3-Kinase (PI3K) Inhibitor for the Treatment of Relapsed Follicular Lymphoma. Ann Pharmacother. 2019 Sep;53(9):954-958. (link)
  11. Morschhauser F et al. On-Target Pharmacodynamic activity of the PI3K inhibitor Copanlisib in paired biopsies from patients with malignant lymphoma and advanced solid tumors. Mol Cancer Ther. 2019. (link)
  12. Ajay K. Gopal, et al. PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma. N Engl J Med 2014;370:1008-18. (link)
  13. Ian Flinn, et al. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. (link)
  14. Nathan H. Fowler, et al. Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021 Mar 8;JCO2003433. (link)
  15. Aliqopa, Prescribing Information 2/2022 (link)

    PI3K Inhibitors in NHL – Combination Therapy

  16. Matthew J. Matasar, et al. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):678-689. (link)
  17. Rahul Lakhotia, et al. Preliminary Results from a Phase II Study of Response-Adapted Therapy with Copanlisib and Rituximab for Untreated Follicular Lymphoma. Blood (2020) 136 (Supplement 1): 39–40. (ASH abstract) (link)

    Adverse Event Management for PI3K Inhibitors

  1. Bruce D. Cheson, et al. Optimal Management of Adverse Events From Copanlisib in the Treatment of Patients With Non-Hodgkin Lymphomas. Clinical Lymphoma, Myeloma and Leukemia 2019; 19 (3), 135-141 (link)
  2. Steven E. Coutré, et al. Management of adverse events associated with idelalisib treatment: expert panel opinion. Leukemia & Lymphoma. 2015; 56:10, 2779-2786. (link)
  3. Naifa L. Busaidy,et al. Management of Metabolic Effects Associated With Anticancer Agents Targeting the PI3K-Akt-mTOR Pathway. J Clin Onc, 2012: 30, 2919-2928. (link)