I. Background
Bayer Pharmaceuticals’ Medical Education department is committed to funding independent medical education initiatives that help to address important healthcare professional educational gaps and improve patient care.
II. General Information and Requirements
CGA Issue Date: | June 23, 2025 |
CGA Due Date: | August 4, 2025 |
Initiation of Program Development: | December 5, 2025 |
Therapeutic Area: | Activating HER2mut Alterations as Actionable Biomarkers in NSCLC
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Type of Initiative: | Satellite symposium at NACLC + online enduring |
Activity Format Examples: | Live program with enduring materials/learner-centered, active-learning/Evidence-based learning & improvement programs preferred |
Primary Target Audience: | Medical Oncologists |
Geographic Scope: | United States |
Expected Monetary Range: | Up to $350,000 |
How to Submit: | 1. Review Bayer Pharmaceuticals Grant Guidelines: https://www.grants-contributions.bayer.com/home/medical-educational-grants 2. Review additional CGA requirements outlined within this document. 3. Submit via Bayer Pharmaceuticals’ online request form: Link |
Questions: | Questions may be submitted to medicaleducation@bayer.com (please reference ‘HER2mut NSCLC’) |
Notification Process: | Upon Grant Review Committee evaluation and assessment, the requestor is notified of the decision via e-mail to the address entered on the Grant Request Form |
III. Proposal Requirements
- Formal letter of request, including:
- Program title
- Brief Program Outline/description
- Program development start date
- Target release date of program (if applicable)
- Rationale and approach to program placement (if applicable)
- Anticipated attendance and breakdown by specialty (if applicable)
- Amount requested
- CME credits offered
- Needs Assessment
- Learning Objectives and Educational Gaps: specific, measurable, performance based.
- Target Audience and Audience Generation: describe the target audience(s) and provide a rationale for how and why this target audience is important to closing the identified healthcare gap. Additionally, describe methods of reaching the target audience(s) including description and rationale for recruitment strategies.
- Educational Method and Design: considers appropriate target audience and learning preferences.
- Venue (if applicable): describe target venue (i.e., distribution amongst academic institutions, large community hospitals and networks, restaurants, and others).
- Meeting Placement Strategy and Institution Vetting Process (if applicable)
- Delivery Format: describe rationale of delivery format.
- Potential Faculty
- Faculty Recruitment and Training Strategy
- Program Development Timeline
- Program Agenda
- Program Budget: detailed budget with rationale including breakdown of costs with clear calculations.
- Educational Outcomes: provide a description of the approach to evaluate the reach and quality of program delivery (minimum outcomes: Moore’s levels 1-4).
- Communication/Activity Update Plan (optional)
- Completed, recent W-9 form
IV. Compliance: grant application must be compliant with ACCME guidelines, free of commercial bias/influence, non-promotional, and fair balanced.
V. Terms and Conditions
- This CGA does not commit Bayer Pharmaceuticals to award a grant or to pay any costs incurred in the preparation of this request.
- Bayer Pharmaceuticals reserves the right to accept or reject any or all applications received as a result of this request or to cancel in part or in its entirety this CGA at any time without prior notification or permission.
- The grant application must be submitted via Bayer Pharmaceuticals’ online request form: https://www.grants-contributions.bayer.com/home/medical-educational-grants.
- All communications about the CGA must come exclusively to Bayer Pharmaceuticals Medical Education, medicaleducation@bayer.com.
VI: Acceptance of a BHC educational grant indicates that you will:
- Reconcile grant funding within 60 days of completion of the educational program.
- Permit a BHC Medical Affairs representative to audit live programs.
- Share activity data and outcomes metrics within 30 days of their availability.
Literature/Data References:
- Herbert Loong, Lin Li, Lin Wu, Tae Min Kim, Arsela Prelaj, Xiaorong Dong, Hye Ryun Kim, Tsung-Ying Yang, Gennaro Daniele, Shun Lu, Yong Fang, Yuki Shinno, Liyun Miao, Nicolas Girard, Jun Zhao, Gerrina Ruiter, Virginie Aris, Rui Li, Paolo Grassi, Xiuning Le. SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease. DOI: 10.1200/JCO.2025.43.16_suppl.8504
- Vivek Subbiah, Bradley McGregor, Ecaterina Dumbrava, Antoine Italiano, Elena Garralda, Aditya Shreenivas, Kohei Shitara, Alison Zhang, Michel Theron, Florian Hiemeyer, Chiara Mussi, Gennaro Daniele. panSOHO: Phase II trial of BAY 2927088 in patients with unresectable or metastatic solid tumors other than NSCLC with HER2activating mutations. DOI: 10.1200/JCO.2025.43.16_suppl.TPS3185
- Xiuning Le, Koichi Goto, Shun Lu, Jan Christoph Brase, Judith Xu, Su-Fen Pu, Izabela Przybytniak, Lidia Mongay Soler, Edward Garon, Antonio Passaro. SOHO-02: Phase III trial of BAY 2927088 in patients with locally advanced or metastatic NSCLC with HER2-activating mutations. DOI: 10.1200/JCO.2025.43.16_suppl.TPS8648
- Girard N., Loong H.H.F., Goh B.-C., Jänne P.A., Dong X., Novello S., Lu S., Daniele G., Kim H.R., Yang T.-Y., Goto K., Zhao J., Tan D.S.W., Li L., Prelaj A., Fang Y., Ghadessi M., Grassi P., Le X., Kim T.M. Phase I/II SOHO-01 study of BAY 2927088 in patients with previously treated HER2-mutant NSCLC: Safety and efficacy results from 2 expansion cohorts. J Thoracic Oncol 2025 20:3 Supplement 1 (S5-S6)
- Passaro A, Brase JC, Xu J, Mongay Soler L, Goto K. A randomized phase III trial evaluating oral BAY 2927088, compared with standard of care, as first-line treatment of locally advanced or metastatic NSCLC harboring HER2-activating mutations (SOHO-02) Ann Oncol Volume 35, Supplement 2S873-S874 September 2024
- Le X., Girard, N., Janne, P.A., Novello, S., Kim, H.R., Loong, H.H., Goh B.C., Lee K.H., Nishino K., Lu, S., Dong, X., Zhao, J., Leal, T.A., Tan, D.S-W., Goto, K., Descamps, T., Brennan, B.J., Li, R., Grassi, P., Kim, T.M. Safety and efficacy of BAY 2927088 in patients with HER2-Mutant NSCLC: Expansion cohort from the Phase I/II SOHO-01 study. J Thoracic Oncol Volume 19, Issue 10, Supplement S4 October 2024
- Goto, K., Brase, J. C., Xu J., Pu, S-F., Montague-Dale, M., Soler, L. M., Passaro, A. SOHO-02: Phase III trial of BAY 2927088 In patients with locally advanced or metastatic NSCLC with HER2-activating mutations. J Thoracic Oncol Volume 19, Issue 10, Supplement, October 2024, Page S660
- Nicolas Girard , Tae Min Kim , Hye Ryun Kim , Herbert H. Loong , Yuki Shinno , Shun Lu , Yong Fang , Jun Zhao , Kazumi Nishino , Ki Hyeong Lee , Liyun Miao , Tomohiro Sakamoto , Enriqueta Felip , Tsung-Ying Yang , Christophe Alfons Dooms , Daniel Shao-Weng Tan , Xiuning Le , Jan Christoph Brase , Paolo Grassi , Koichi Goto Safety and anti-tumor activity of BAY 2927088 in patients with HER2-mutant NSCLC: Results from an expansion cohort of the SOHO-01 phase I/II study. J Clin Oncol 42, 2024 (suppl 17; abstr LBA8598)
- Uzunbas G.K., McVeigh Q., Gupta A., Hoyt S., Cherniack A., Siegel F., Siegel S., Meyerson M., Greulich H. Mechanisms of resistance to BAY 2927088, the first reversible inhibitor targeting EGFR exon 20 insertion mutations in non-small cell lung cancer. Mol Cancer Ther (2023) 22 (12_Supplement): A037; 35th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
- Loong H.H.F., Daniele G., Yang T.-Y., Leal T.A., Goto K., Shinno Y., Nishino K., Sakamoto T., Felip E., Ruffinelli J.C., Gallot N., Wang Z., Chen C., Brennan B., Pu S.-F., Kornacker M., Grassi P., Le X., Tan D.S.W., Goh B.-C. Early evidence of efficacy in patients (pts) with non-small cell lung cancer (NSCLC) with HER2 exon20 insertion (ex20ins) mutations treated in a phase I study with BAY 2927088. Ann Oncol 2023 34 Supplement 2 (S761-S762)
- Uzunbas G.K., McVeigh Q., Gupta A., Hoyt S., Doucette K., Keshishian H., Carr S., Yang X., Root D., Cherniack A.D., Siegel F., Siegel S., Meyerson M., Greulich H. Mechanisms of resistance to BAY 2927088, the first reversible inhibitor targeting EGFR exon 20 insertion mutations in non-small cell lung cancer. Cancer Res (2023) 83 (7_Supplement): 433.
- Siegel F., Karsli-Uzunbas G., Kotynkova K., McVeigh Q., Siegel S., Korr D., Schulze V., Berger M., Beckmann G., Cherniack A., Meyerson M., Greulich H. Preclinical activity of BAY 2927088 in HER2 mutant non-small cell lung cancer. Cancer Res (2023) 83 (7_Supplement): 4035
- Tan D., Goto K., Loong H.H.F., Yang T.-Y., Gadgeel S., Massarelli E., Daniele G., Le X., Shinno Y., Murakami H., Sakamoto T., Ruffinelli J.C., Lu S., Zhang Y., Kim T.M., Brennan B.J., Chen C., Joosten M., Wang Z., Pu S.-F., Bao W., Kornacker M., Ferraldeschi R., Grassi P., Goh B.C. An open-label, first-in-human study of BAY2927088 in patients with advanced non-small cell lung cancer (NSCLC) harboring an EGFR and/or HER2 mutation. Cancer Res (2023) 83 (8_Supplement): CT126
- Siegel F., Siegel S., Graham K., KarsliUzunbas G., Korr D., Schroeder J., Boemer U., Hillig R.C., Mortier J.,
Niehues M., Golfier S., Schulze V., Menz S., Kamburov A., Hermsen M., Cherniak A., Eis K., Eheim A., Meyerson M., Greulich H. BAY 2927088: The first non-covalent, potent, and selective tyrosine kinase inhibitor targeting EGFR exon 20 insertions and C797S resistance mutations in NSCLC. Eur J Cancer 2022 174 Supplement 1 (S9-S10); 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics - C. Chen, B. Ploeger, M. Damaske, S. Reif, S. Pu, P. Grassi, B. Brennan. Concentration-QT Analysis for BAY 2927088 Indicates No Clinically Relevant QTc Interval Prolongation. Clin Pharmacol Ther 117 Supplement S1 (S31); ASCPT 2025; DOI: 10.1002/cpt.3607
- B. Brennan, M. Damaske, F. Hafner, U. Muenster, A. Lender, J. Joseph, S. Reif, S. Prendergast, P. Lienau, B. Ploeger, C. Chen. Effect of food and esomeprazole on the pharmacokinetics of BAY 2927088. Clin Pharmacol Ther 117 Supplement S1 (S49); ASCPT 2025; DOI: 10.1002/cpt.3607
- C. Chen, M. Damaske, F. Hafner, R. Frick, S. Reif, S. Prendergast, P. Lienau, B. Ploeger, B. Brennan. Clinical Drug‐Drug Interaction Studies Investigating the Effect of BAY 2927088 on P‐gp And BCRP using Dabigatran Etexilate and Rosuvastatin. Clin Pharmacol Ther 117 Supplement S1 (S80); ASCPT 2025; DOI: 10.1002/cpt.3607
- B. Brennan, M. Damaske, F. Hafner, I. Piel, C. von Buehler, M. Niehues, N. Jungmann, S. Reif, S. Prendergast, P. Lienau, B. Ploeger, C. Chen. Clinical Drug‐Drug Interaction Studies through Cytochrome P450 3A (CYP3A) and P‐glycoprotein (P‐gp) for BAY 2927088 using Itraconazole (ITZ), Carbamazepine(CBZ) and Midazolam (MDZ). Clin Pharmacol Ther 117 Supplement S1 (S93-S94); ASCPT 2025; DOI: 10.1002/cpt.3607