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Oncology Areas of Interest

Qualified researchers are invited to submit research proposals, according to the guidance and instructions found on www.pfizer.com/ISR. A proposal requesting Pfizer support (e.g., funding and/or drug supply) is not a guarantee of acceptance or approval of that proposal. Decisions on support for submissions are made by the applicable Pfizer Global Reviewers. A formal notification regarding the status of your application will be sent once a decision is reached. Pfizer support will only be extended upon the execution of a research agreement. For any questions, please send an email to [email protected].

Oncology compounds are listed below alphabetically. For each compound, the areas of interest are listed in order of medical and scientific unmet need.

Question Pairs: 
Question: 

avelumab

Answer: 

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.

Please click here to view submission deadlines for the U.S. & Canada. Please click here to view submission deadlines for all other countries.

In general, the Alliance will give priority to investigator-sponsored research proposals that aim to explore:

  • 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)
  • Use of avelumab in early stage disease
  • Further understanding of the clinical usefulness of engaging the innate immune system with avelumab
  • Duration of therapy evaluations
  • Definition/identification of responders in the ‘tail of the curve’
  • Understanding of primary, adaptive, and/or acquired resistance to IO therapy
  • Identification of other biomarkers or biomarker-defined subgroups

Preference will also be given to the following tumor types:

  • Genitourinary (prioritizing Renal Cell Carcinoma and Urothelial Cancer)
  • Gastrointestinal (prioritizing Gastric Cancer)
  • Squamous Cell Carcinoma of the Head & Neck (SCCHN)
  • Non-melanoma Skin Cancer (NMSC) (prioritizing Merkel Cell Carcinoma)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Virus-Associated Cancers

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.)

Question: 

axitinib

Answer: 

Research areas to be considered for Pfizer support include:

  • Metastatic Renal Cell Carcinoma (mRCC) 1L treatment

    • 1L immunotherapy (IO) combinations
  • mRCC Second-Line (2L) treatment

    • axitinib dose individualization
    • Duration of treatment (DoT), treatment (tx) beyond progression, Re-challenge
    • Long term responders, complete responders
    • Adverse event (AE) management that impacts practice
    • New combinations in 2L+
    • axitinib re-challenge post Immunotherapy (IO)+ axitinib combinations
  • mRCC / IO

    • Post IO efficacy/ safety
    • Sequence (single agent and combinations)
    • IO combinations (all lines)
    • IO-combination mechanistic data (pre-clinical or clinical)
  • mRCC biomarkers/TR

    • Immuno-modulatory properties
    • Effect on tumor micro-environment
  • Gastrointestinal Stromal Tumors (GIST): Combinations, Biomarkers
  • Pancreatic Neuroendocrine Tumors (pNET): Well-differentiated G3 tumors, Sequences, Biomarkers
Question: 

bosutinib

Answer: 

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
Question: 

crizotinib

Answer: 
  • 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

Question: 

dacomitinib

Answer: 

Research areas to be considered for Pfizer support include:

  • Central Nervous System (CNS) outcomes in 1L EGFR+
  • NSCLC for patients with and without brain metastases

    • Understanding dacomitinib resistance in particular the emergence rates of T790M
    • Documenting the outcomes of T790M patients treated with osimertinib post dacomitinib
    • Validating therapy management techniques to maximize dacomitinib benefit
  • 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

Question: 

enzalutamide

Answer: 

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

Question: 

inotuzumab ozogamicin

Answer: 

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.
Question: 

gemtuzumab ozogamicin

Answer: 

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 veno-occlusive disease (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
Question: 

glasdegib

Answer: 

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
Question: 

lorlatinib

Answer: 

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

Question: 

palbociclib

Answer: 

Breast Cancer

Research areas to be considered for Pfizer support include:

  • 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

Question: 

sunitinib

Answer: 

Research areas to be considered for Pfizer support include:

  • Renal Cell Carcinoma (RCC) adjuvant

    • Data on epidemiology and patient selection (TNM, UISS, other)
    • safety and efficacy data from clinical practice
    • Outcomes in first-line (1L) after adjuvant SUT / TKI
    • Treatment sequence post adjuvant sunitinib (IO vs. IO+IO vs. IO+TKI vs. TKI)
    • Dose individualization strategies to manage toxicities
    • Other histologies (sarcomatoid)
  • Metastatic Renal Cell Carcinoma (mRCC) first-line (1L)

    • Alternative schedule / treatment individualization
    • Treatment beyond progression, Re-challenge
    • Adverse Event (AE) management that impacts practice
    • Long term responders, complete responders
    • Activity in intermediate/poor risk populations
    • Patient selection strategies
  • mRCC / IO / TKI

    • Efficacy/safety for Sequence (Pre/post IO) or combinations with IO (any line)
  • mRCC biomarkers/TR

    • Immuno-modulatory properties
    • Effect on tumor micro-environment
    • Epigenetics
  • Gastrointestinal Stromal Tumors (GIST): Combinations, Biomarkers
  • Pancreatic Neuroendocrine Tumors (pNET): Well-differentiated G3 tumors, Sequences, Biomarkers
Question: 

talazoparib

Answer: 

Research areas to be considered for Pfizer support include:

  • Novel combinations with targeted therapies, including immuno-modulating agents
  • Combination with radiation therapy
  • Use in BRCAm, DNA Damage Response (DDR)-deficient or molecularly unselected tumors, as appropriate
  • Strategies to overcome mechanism of resistance