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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: 

Research areas to be considered for Pfizer support include:

  • Chronic Myeloid Leukemia (CML)
    • Dose optimization
    • Mechanisms of toxicity
    • Biomarkers of efficacy/toxicity
    • Safety/Efficacy in Real world populations
    • Special populations
    • Treatment-free remission (TFR)
    • Sequencing/Switch with other TKIs
  • Sequence/Combine with novel agents
    • Immunotherapy
    • Pfizer pipeline
Question: 

crizotinib

Answer: 

Research areas to be considered for Pfizer support include:

  • Sequencing ALK-inhibitors: collecting long term data for crizotinib-led sequence
  • Expanding the dataset for cMET exon 14 advanced Non-Small Cell Lung Cancer (NSCLC)
  • Establishing and validating CMET exon 14 testing method
  • Defining ALK and ROS resistance patterns in NSCLC
  • ROS-1+ve NSCLC: collecting long term outcomes from Real World Data (RWD)
  • cMET amplified advanced NSCLC
  • Collecting long term data for outcomes in Inflammatory Myofibroblastic Tumor (IMT)
  • Other ALK, ROS1 and MET+ tumors based on emerging science and lifecycle
  • Establishing and validating ROS1 testing methods

Out of Scope: establishing and validating new ALK 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: 

gedatolisib

Answer: 

Research areas to be considered for Pfizer support include:

  • ER+ HER2- Metastatic Breast Cancer (MBC)
  • Neo-adjuvant HER2+ breast cancer—early stage/local adjuvant combinations with targeted/chemotherapy
  • Neo-adjuvant or window studies in immunotherapy (IO) combinations
  • Combinations with PARP inhibitors Combination with antibody-drug conjugates (ADC)
  • Combination with antibody-drug conjugates (ADC)
Question: 

gemtuzumab ozogamicin

Answer: 

Research areas to be considered for Pfizer support include:

  • Explore optimal dosing regimens and further evaluation of fractionated regimen
  • AE management
  • Registry data/RWD to evaluate efficacy and safety outcomes
  • Activity of GO in specific sub-populations (e.g. NPM1, FLT-3, CBF)
  • Efficacy in R/R AML as combination therapy
  • Combinations including: smoothened inhibitors, immunotherapy, FLT-3 inhibitors, IDH1/2 inhibitors, bcl-2 inhibitors, liposomal chemotherapy, HDAC inhibitors
  • Use in the setting of minimal residual disease
  • Acute promyelocytic leukemia
  • Hematopoietic Stem Cell Transplantation (HSCT)
Question: 

glasdegib

Answer: 

Research areas to be considered for Pfizer support include:

  • Translational research correlating outcomes to stem cell biology with focus on mechanisms of resistance and biomarkers of response in haematological and solid tumors
  • Combination therapy approaches in AML with novel molecules
  • Use in the setting of minimal residual disease
  • Use in the setting of maintenance therapy
  • Evaluation in the setting of autologous or allogeneic haematopoietic stem cell transplant

Out of scope: Any pediatric proposals with glasdegib

Question: 

inotuzumab ozogamicin

Answer: 

Research areas to be considered for Pfizer support include:

  • Relapsed/refractory (R/R) Acute Lymphoblastic Leukemia (ALL)
    • Dose Optimization
    • Therapy management including VOD
    • Combination approaches
    • Real world data studies/Registry data/Data mining
    • Cost data/budget impact
    • Mechanisms of resistance
  • 1L ALL
  • Minimal residual disease – positive (MRD +) ALL
  • ALL in Pediatrics/Adolescents and Young Adults (AYA)
  • Maintenance therapy in ALL
  • Post HSCT in ALL
  • Sequence/Combine with novel agents
    • Immunotherapy
    • Pfizer pipeline 
  • Non-Hodgkin Lymphoma (NHL) in combination/sequence with novel agents
  • Tumour agnostic targeting of CD22 - 
Question: 

lorlatinib

Answer: 

Research areas to be considered for Pfizer support include:

  • Expand the understanding of lorlatinib use in advanced ALK+ NSCLC focusing use post-2nd generation ALK TKIs including activity in specific mutation types
  • Defining efficacy in CNS using endpoints not currently being studied (for example RANO criteria)
  • Validating therapy management techniques
  • Sequencing ALK-inhibitors: Collecting data on clinical outcomes and resistance patterns
  • ROS-1+ NSCLC including data post non-crizotinib ROS TKIs and ROS resistance patterns
  • Rational combination with other agents to treat or prevent development of lorlatinib-resistance
  • Other ROS1 or ALK+ tumors
  • Establishing and validating new blood-based ALK testing method
 
Out of Scope: Adjuvant NSCLC, studies exploring immunotherapy combinations, Pediatric studies until dose finding is complete, establishing and validating new tissue-based ALK testing methods, ALK+ ALCL.
 
Question: 

palbociclib

Answer: 

Breast Cancer

Research areas to be considered for Pfizer support include:

  • Treatment sequencing in HR+ Metastatic Breast Cancer (MBC) and other subgroups
  • Special populations including safety and efficacy
  • Studies that utilize Real World Data (RWD) 
  • Studies that utilize Patient Reported Outcomes (PRO)
  • Differentiation among CDK 4/6 inhibitors
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:

  • Use in gBRCAm or other DNA Damage Response (DDR) deficient tumors (as single agent or combination) including detection and patient selection
  • Combination with radiation therapy (XRT) in appropriate tumors
  • Combinations with DNA damaging agents or targeted therapies
  • Strategies to overcome mechanism of resistance
  • Preclinical work to support talazoparib in multiple tumor types
  • Single agent in gBRCAm Metastatic Breast Cancer (MBC)