Oncology Areas of Interest

Merck KGaA, Darmstadt, Germany, and Pfizer Inc formed a strategic alliance to develop and commercialize Merck KGaA’s anti-PD-L1 asset known as avelumab.

The Alliance will give priority to investigator-sponsored research proposals that focus on genitourinary tumors (prioritizing renal cell carcinoma and urothelial cancer).

In addition, investigator-sponsored research proposals that focus on the following themes may be considered:

• Safety and efficacy of novel combinations with avelumab and/or sequencing based on strong scientific rationale and/or developing trends in the field (monotherapy trials will be de-prioritized)
• Further understanding of the clinical usefulness of engaging the innate immune system with avelumab
• Duration of therapy evaluations
• Identification of other biomarkers or biomarker-defined subgroups e.g. long-term responders
• Consider continuing to support studies that have demonstrated proof of concept
• Understanding of primary, adaptive, and/or acquired resistance to IO therapy

Please note: Any proposal involving combination with another Pfizer asset should be submitted via the Pfizer portal and any proposal involving combination with another Merck KGaA asset should be submitted via its company portals (www.ist.emdserono.com for U.S. & Canada, and www.iss.merckbiopharma.com for all other countries).

Metastatic Renal Cell Carcinoma (RCC)

• First Line (1L) Immuno-oncology (IO) combinations with supporting evidence
• Efficacy/Safety for combinations with IO post-1L
• Efficacy/Safety for sequencing post-1L
• TKI+IO mechanistic data
• Real World Data (RWD) studies

Non-RCC: Areas of high unmet medical need with strong evidence supporting the use of anti-angiogenic therapies alone or in combination

Proposals for interventional, non-interventional, basic science, or other studies that:

• Demonstrate the value or economic benefit of the biosimilar
• Incorporate Real World Data and/or Patient Reported Outcomes
• Evaluate the integration of the biosimilar with a standard-of-care regimen in an approved indication not previously evaluated
• Explore rational treatment combinations with other Pfizer medicines

Out of Scope:

• Head-to-Head Comparative clinical trials of the biosimilar versus the originator drug
• Studies in a country in which the biosimilar has not received regulatory approval
• Country in which commercial supply of the biosimilar is not available (there may be very limited exceptions)
• Pediatric Trials

Pfizer is accepting proposals for independently sponsored research with binimetinib from US and Canadian investigators in the following research areas. Investigators interested in sponsoring research studies in South Korea or Japan should apply to Ono Pharmaceutical Co. Ltd. Investigators interested in sponsoring research in Israel should apply to Medison. Investigators interested in sponsoring research in all other geographies not noted above should apply to Pierre Fabre.

BRAF mutant melanoma:

In combination with encorafenib,

• adjuvant treatment
• rational combinations to overcome MAPK pathway treatment resistance
• immunotherapy combination treatment
• studies that utilize biomarker informed treatment
• sequencing and retreatment strategies

BRAF mutant colorectal cancer:

• rational combinations with encorafenib and cetuximab and/or other agents to overcome MAPK pathway resistance
• immunotherapy combination treatment
• studies that utilize biomarker informed treatment
• sequencing and retreatment strategies

Other malignancies:

• combination with encorafenib in BRAF driven mutations
• novel combinations with other agents when supported by preclinical data

Studies incorporating real world data (RWD) or patient reported outcomes (PRO)

Out of scope: binimetinib monotherapy studies

Real World Data analyses:

• Pragmatic design on prospective studies / Novel analysis to investigate treatment-free remission
• Subset patient population analyses (elderly, by comorbidity, by frailty index)
• Optimal sequencing or switching combinations with other TKIs
• Exploration of different interventions / instruments to improve patient adherence
• Ways to manage more common adverse events

Explorative studies in combination with other novel molecules:

• To enhance / deepen response in CML
• Innovative treatment-free-remission studies

Translational research in human tissues as add-on studies to ongoing clinical trials:

• Biomarker studies that identify resistance
• Biomarker studies to predict response / resistance
• Biomarker studies that predict toxicities

• ROS1+ NSCLC: Collecting long term outcomes from Real World Data (RWD)
• Sequencing ALK-inhibitors: Collecting long term RWD Overall Survival (OS) for crizotinib-led sequences

Out of Scope: Establishing and validating new ALK, ROS or MET testing methods, adjuvant NSCLC, Anaplastic Large Cell Lymphoma (ALCL), pediatric studies, immunotherapy combinations

• Central Nervous System (CNS) outcomes in 1L EGFR+ NSCLC for patients with and without brain metastases
• Confirm dacomitinib mechanisms of resistance, including T790M
• Characterize optimal sequencing strategies and documenting the outcomes of T790M patients treated with osimertinib post dacomitinib
• Validating optimal dosing modification strategies to maximize dacomitinib benefit
• Strategic Combinations in 1L EGFR+ mNSCLC, including with VEGF mAb
• Exploring the potential of dacomitinib post- osimertinib progression

Out of Scope: Unselected NSCLC, HER-2 NSCLC, post-EGFR TKI use, immunotherapy combinations, establishing and validating new EGFR testing methods, other EGFR or HER2 driven tumors, adjuvant setting

Pfizer is accepting proposals for independently sponsored research with encorafenib from US and Canadian investigators in the following research areas. Investigators interested in sponsoring research studies in South Korea or Japan should apply to Ono Pharmaceutical Co. Ltd. Investigators interested in sponsoring research in Israel should apply to Medison. Investigators interested in sponsoring research in all other geographies not noted above should apply to Pierre Fabre.

BRAF mutant melanoma:

In combination with binimetinib,

• adjuvant treatment
• rational combinations to overcome MAPK pathway treatment resistance
• immunotherapy combination treatment
• studies that utilize biomarker informed treatment
• sequencing and retreatment strategies

BRAF mutant colorectal cancer:

• combination with binimetinib
• combinations with cetuximab +/- binimetinib in selected patient populations
• combinations with cetuximab +/- binimetinib and/or novel agents to overcome MAPK pathway resistance
• studies that utilize biomarker informed treatment

Other BRAF malignancies:

• combination with binimetinib
• novel combinations with other agents when supported by preclinical data

Studies incorporating real world data (RWD) or patient reported outcomes (PRO)

Out of scope: encorafenib monotherapy studies

Astellas and Pfizer jointly develop enzalutamide and jointly commercialize it in the United States. IIR proposals are currently accepted from the United States only through the Astellas portal at www.globalisrportal.force.com. Questions regarding the Astellas process may be sent to [email protected]

Prostate Cancer

• Combinations with established and novel agents
• Early stages of prostate cancer
• Biomarkers to inform response, resistance and treatment decisions
• Understanding mechanisms of AR inhibitor action and resistance

Out of Scope: All tumor types other than prostate cancer

Real world data (RWD) studies in first-line (1L) and relapsed-refractory (R/R) AML:

• Prospective/Retrospective collection of RWD to determine efficacy and safety in specific patient populations (e.g. ELN classification, molecular subgroup, cytogenetic risk)
• Therapy management of VOD / other AE’s
• Risk factors for and mechanism of VOD
• Patient-reported outcomes in different populations including quality of life and resource utilization

Explorative studies in combination with other marketed novel agents in AML:

• Proof of concept biomarker driven strategies with combination/sequencing approach of gemtuzumab ozogamicin (GO) with targeted therapies
• Proof of concept combination/sequencing approaches of GO with novel mechanisms of action (MOAs) /treatment modalities in AML
• Strategies to overcome resistance

Explorative studies as single agent or in combination with other marketed novel agents to address other questions in AML:

• As pre-HSCT conditioning or post-HSCT maintenance treatment;
• Treatment of MRD
• Maintenance therapy

Explorative studies on combinations / sequences with standard-of-care (SOC) and novel agents in acute myeloid leukemia (AML), or myelodysplastic syndrome, or myelofibrosis.

Explorative studies in combination with other marketed novel agents in:

• Post-allogeneic or autologous HSCT in hematologic malignancies including high-risk populations for relapse
• Post-allogeneic HSCT GVHD treatment / prevention
• Maintenance in non-transplant eligible hematologic malignancies

Real world data analysis on therapy management and patient-reported outcomes (quality of life, cost of care, health resource utilization.)

Translational research from clinical studies:

• Studies in hematologic malignancies and solid tumors
• Identifying potential stem cell biomarkers of response
• Mechanisms of resistance
• Genetic determinants of outcomes

Exploration as maintenance therapy in B-cell malignancies (ALL and Lymphoma) as single agent or in combination with standard-of-care (SOC)/novel molecules. Maintenance studies can be in 1L, R/R, post-HSCT, or post-CART. Biomarker studies in these settings would also be of interest.

Exploration in the frontline treatment of ALL:

• Innovative combinations or sequencing with novel molecules (CART, bi-specific, small molecules, BCL2 inhibitor, etc)
• MRD setting

Real world data analysis in relapsed/refractory adult ALL:

• Registry studies exploring efficacy / safety in different subset populations;
• Studies supporting therapy management and dose optimization;
• Mechanisms of resistance;
• Mechanisms of VOD / VOD susceptibility;
• Patient-reported outcomes in different subset populations including cost-of-care, health resource utilization, caregiver needs.

• Further defining efficacy in CNS (for example RANO criteria)
• Validating therapy management techniques
• Collecting RWD on lorlatinib outcomes in second-line (2L) treatment post-alectinib or brigatinib
• Expanding the lorlatinib dataset for 2L ROS1+ NSCLC
• Defining lorlatinib ALK and ROS resistance patterns
• Rational combinations to treat or prevent lorlatinib resistance

Out of Scope: Establishing and validating new ALK, ROS or MET testing methods, adjuvant NSCLC, Anaplastic Large Cell Lymphoma (ALCL), pediatric studies, immunotherapy combinations

Breast Cancer

• Novel treatment strategies to overcome resistance following initial treatment with a CDK4/6 inhibitor + endocrine therapy
• Studies that utilize Real World Data (RWD)
• Studies that utilize Patient Reported Outcomes (PRO)

Out of scope: all other tumor types beyond breast cancer

Proposals for interventional, non-interventional, basic science, or other studies that:

• Explore incorporating the biosimilar into a novel combination treatment, existing combination treatment in a novel sequential therapy or novel exploratory end-points within label indications.
• Explore treatment optimization within a labelled indication
• Value-Based modeling evaluating the impact of medical quality improvements to prevent acute life-threatening conditions such as infections and atrial fibrillation in CLL, DLBCL and/or FL patients treated with rituximab biosimilars
• Studies improving outcomes in geriatric oncology patients who are eligible for rituximab or supportive care
• Studies improving hospital processes to prevent infections in high risk oncology patients who are treated with biosimilars (supportive care and rituximab)
• Studies evaluating switching rituximab biosimilars

Out of Scope:

• Head-to-Head Comparative clinical trials of the biosimilar versus the originator drug
• Analytical characterization of the rituximab biosimilar
• Pediatric Trials

Metastatic Renal Cell Carcinoma (RCC)

• Efficacy/Safety for sequencing pre- and post-Immuno-Oncology (IO)
• Patient selection strategies in First Line (1L)
• Real World Data (RWD) studies

Out of scope: all other tumor types

• Novel combinations with drugs with new mechanisms of action
• Use in maintenance setting
• Studies of sequencing, long responders and/or therapy management including Real World Data (RWD) sources
• Studies of efficacy in breast metastases to the brain, including RWD sources

Out of Scope:

• Breast studies in the (neo) adjuvant setting
• Breast studies in non-gBRCA mutation populations

Proposals for interventional, non-interventional, basic science, or other studies that:

• Demonstrate the value or economic benefit of the biosimilar
• Incorporate Real World Data and/or Patient Reported Outcomes
• Evaluate the integration of the biosimilar with a standard-of-care regimen in an approved indication not previously evaluated
• Explore rational treatment combinations with other Pfizer medicines

Out of Scope:

• Head-to-Head Comparative clinical trials of the biosimilar versus the originator drug
• Studies in a country in which the biosimilar has not received regulatory approval
• Country in which commercial supply of the biosimilar is not available (there may be very limited exceptions)
• Pediatric Trials