Oncology Areas of Interest

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:

• Treatment-Free Remission
• Incidence of and risk factors for Adverse Events (AEs) of Special Interest (e.g. Cardiovascular AEs) in Real World
• Management of common and long-term adverse events including dose modification / individualization
• Exploration of different interventions / instruments to improve patient adherence and assess quality of life

ROS1 positive NSCLC

Generate retrospective Real-World Data (RWD) to evaluate:

• Long-term outcomes, including overall survival (OS)
• Crizotinib in first-line
• Subsequent treatments

Out of Scope

• Establishing and validating new ALK, ROS or MET testing methods
• Adjuvant NSCLC
• Anaplastic large cell lymphoma (ALCL), IMT (inflammatory anaplastic lymphoma kinase [ALK]-positive myofibroblastic tumors) and pediatric studies
• Immunotherapy combinations
• ROS1 driven tumors (excluding NSCLC)
• ALK and MET driven tumors

Metastatic Non-Small Cell Lung Cancer (mNSCLC) 
•    Real world data (RWD) studies in first-line (1L) EGFR mutant mNSCLC including studies focused on EGFR exon 21 L858R mutations from Latin America, Africa, Middle East, and Asian countries (except Japan)
•    Combination therapy in 1L EGFR mutant mNSCLC, including with VEGF targeted agents

Out of Scope
•    Unselected NSCLC
•    HER2 NSCLC and other HER2 driven tumors
•    Post-EGFR TKI use including post osimertinib
•    Immunotherapy combinations
•    Establishing and validating new EGFR testing methods
•    EGFR driven tumors (excluding NSCLC)
•    Adjuvant setting
 

• Advanced multiple myeloma and basic science
  • Dosing and administration optimization including Health-Related Quality of Life (HRQoL) and Patient Reported Outcomes (PRO) studies
  • Preclinical studies (biomarkers and mechanisms of high or reduced response to elranatamab; predictors of elranatamab associated toxicities, explore drug combinations)
• Earlier lines of multiple myeloma therapy
  • Newly Diagnosed Multiple Myeloma (NDMM) or 1st relapse Relapsed Refractory Multiple Myeloma (RRMM)
  • Combinations/sequence with novel agents or standard of care therapy
  • Minimal Residual Disease (MRD) directed/guided treatment strategies
  • Consolidation and/or maintenance therapy
  • Populations of high unmet need underserved by current SOC
• Malignancies targetable by BCMA directed therapy
  • AL Amyloidosis
  • High-risk smoldering myeloma
  • Solitary plasmacytoma

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

• New approaches for treatment of prostate cancer, including drug and non-drug (modality) combinations
• Research in early stages of prostate cancer
• Adverse event management under standard enzalutamide dosing
• Biomarkers to inform response, resistance and treatment decisions
• Patient reported outcomes and quality of life in Prostate Cancer
• New screening, artificial intelligence, & diagnosis technology in conjunction with Prostate Cancer treatment
• Understanding mechanisms of androgen receptor inhibitor action and resistance
• Treatment of oligometastatic disease

Out of Scope:

All tumor types other than prostate cancer

Improving outcomes of newly diagnosed Acute Myeloid Leukemia (AML) patients in combination with standard chemotherapy:

• Studies supporting therapy management risk factors, susceptibility and mechanism of VOD and other common AEs
• Treatment patterns, diagnosis and risk stratification correlated with outcomes
• Sequencing/combination with novel agents
• Patient-reported outcomes, health-related quality of life and innovative uses of big data

Exploration of role of Inotuzumab in front-line treatment of ALL*

• Studies incorporating comparator to SOC
• Studies expanding on existing evidence

Exploration in relapsed/refractory Acute Lymphocytic Leukemia (ALL):

• Real World Data (RWD) exploring efficacy / safety or Health Economics and Outcomes Research in different subset populations
• Pre- and Post-CART
• Studies supporting therapy management and dose optimization
• Addressing resistance mechanisms

* InO in combination with highly intensive chemotherapy are out of scope

• 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 biomarker driven concepts integrating palbociclib into treatment strategies
• 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

Urothelial Carcinoma

• Safety and efficacy of combinations with sasanlimab and/or sequencing based on strong scientific rationale and/or developing trends in the field of Non-Muscle Invasive Bladder Cancer (NMIBC)
• Validation of anti-PD-1 and/or Standard of Care therapy management techniques in NMIBC
• Collection of Real-World Data (RWD) experience in NMIBC
• Safety and efficacy of innovative combinations with sasanlimab in NMIBC and/or neoadjuvant/adjuvant Muscle Invasive Bladder Cancer (MIBC) and bladder sparing approaches
• Assessment of biomarkers to inform response, resistance, and treatment decisions in NMIBC

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

NOTE: only proposals from China will be considered

Lung Cancer:

• Sugemalimab mechanism of action (antibody-dependent cellular phagocytosis, etc.)
• Non-Small Cell Lung Cancer (NSCLC) neoadjuvant therapy
• Unresectable locally-advanced NSCLC therapy
• Advanced NSCLC immunotherapy real world evidence
• Small-Cell lung cancer therapy
• Immunotherapy combinations in lung cancer
• Special population therapy
• Late-line therapy after targeted therapy or previous immunotherapy failure
• Immunotherapy biomarker and microenvironment
• NSCLC adjuvant therapy

Out of Scope:

• Establishing PD-L1 testing methods
• Pediatric studies

Prostate Cancer

• Combination treatment in metastatic Castration Resistant Prostate Cancer (CRPC) and metastatic Castration Sensitive Prostate Cancer (CSPC), particularly novel innovative combination approaches including radiotherapy and targeted agents
• Strategies to prevent/overcome resistance
• Therapy management studies for talazoparib combinations

Out of Scope:

• Breast cancer, pediatric studies, hematology, rare tumors, pancreatic cancer, single agent in Non-Small Cell Lung Cancer (NSCLC) and ovarian cancer
• Combinations with chemotherapy (except temozolomide)
• Combinations with immune checkpoint inhibitors

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