アステラス 研究者主導研究支援プログラム

Practice informing^*:
1:Chemotherapy regimens not evaluated in Zolbetuximab GC/GEJC development studies
2:HER2-ve, CLDN18.2+ locally advanced (LA) unresectable or metastatic GC/GEJC patient sub-segments
3:Adverse event management (prevention and treatment) 
4:Second line+ or treatment sequencing in HER2-ve, CLDN18.2+ LA unresectable or metastatic GC/GEJC

Proof of Concept^*:
5:CLDN18.2 co-expressing tumors for combination with respective targeted therapies for GC/GEJC

Biomarkers^*:
6:Biology of Resistance pathway/overcoming resistance pathway 
7:Biomarker co-expression and testing practices in GC/GEJC

^*CLDN18.2 testing in ISR studies is recommended to be conducted with the Ventana assay.

The following proposal types will not be considered at this time:
1:Duplicative with Zolbetuximab development program/ISRs^**
2:Evaluation of altered route, dose or administration methodology or schedule or any deviation from prescribing information
3:Combinations with investigational therapies
4:Low CLDN18.2 expressing (<50% of tumor cells with moderate to strong membranous staining) GC/GEJC and other tumors

^**HER2-ve, CLDN18.2+ve resectable GC/GEJC and CLDN18.2+ve Pancreatric cancer out of scope due to ongoing development program in Astellas

Practice Informing:
●Adverse Event prevention, treatment and mitigation
●Retreatment
・In patients previously exposed to enfortumab vedotin in locally advanced/metastatic urothelial cancer (la/mUC).
●Clinical resistance
・In patients previously exposed to enfortumab vedotin.

Proof of Concept:
●Combinations/ sequences with targeted therapies in la/mUC
Health Economics Outcomes Research (HEOR):
●Patterns and outcomes of retreatment in urothelial cancer (UC)

The following proposal types will not be considered at this time:
●Research for EV duplicative with: clinical development program including EV-202^**, ongoing ISR program, or ongoing/planned HEOR studies
●Evaluation of altered route, dose or schedule of EV
●Combinations of EV with investigational/unapproved agents.
●Economic models and outcomes with EV
●Preclinical models of resistance with EV
●Nectin-4 as a predictive biomarker that is duplicative with the development program

^* Nectin-4 expression testing is not required for UC　[if Nectin-4 testing desired by investigator for UC, then testing is required via separate agreement with Q2 Solutions]. 
^** Tumors included in EV-202 Trial are: HR+/HER2- Breast Cancer, Triple Negative Breast Cancer (TNBC), Squamous Non-Small Cell Lung Cancer (SNSCLC), Non-Squamous Non-Small Cell Lung Cancer (NSNSCLC), Head and Neck Cancer and Gastric, Gastroesophageal Junction or Esophageal Cancer. This includes any stage, all tumor associated subtypes and combinations until tumor development plan is implemented.

●Novel Hormonal Therapy (NHT) Rechallenge post NHT use in earlier stage of prostate cancer.
●Treatment approaches utilizing enzalutamide as backbone therapy, including treatment with new combinations.
●AE management under standard enzalutamide dosing.
●Biomarkers to inform response, resistance and treatment decisions.
●Patient reported outcomes and QoL in Prostate Cancer.
●New screening, artificial intelligence (AI), and diagnosis technology in conjunction with Prostate Cancer treatment.
●Understanding mechanisms of AR inhibitor action and resistance.
●Treatment of oligometastatic disease.

The following proposal types will not be considered at this time:
●All tumor types other than prostate cancer.
●Country-specific studies where there is no rationale for data generation in sub-populations.
●Healthcare Resource Utilization (Cost Analysis).
●Unapproved enzalutamide dosing.

●FLT3 mutation positive (FLT3 m+) malignancies, acute myeloid leukemia (AML) and other (high risk myelodysplastic syndromes (HR-MDS)).
●Targeted drug combinations with gilteritinib in FLT3 m+ AML, sequencing with FLT3 inhibitors.
●Maintenance therapy in FLT3 m+ AML.
●Minimal residual disease (MRD) and impact on treatment outcomes in gilteritinib treated AML patients, mechanisms of resistance and allelic ratio.

The following proposal types will not be considered at this time:
●Pediatric studies.
●Wild type FLT3 acute myeloid leukemia (AML) or any other malignancy
●Combination with other FLT3 inhibitors and head-to-head studies with other FLT3 inhibitors.

・Real world outcomes-based research using a large scale clinical database/patient registry for assessing efficacy and safety in specific sub-groups of OAB patients which can help better characterize the place of mirabegron in OAB treatment (data availability within 1 to 2 years). 
・Patient centric outcomes, novel associated PROs, caregivers’ QoL etc. with mirabegron use. 
・Differentiation with antimuscarinics in relation to anticholinergic burden in vulnerable patients e.g., elderly with comorbidities and polypharmacy, etc.

The following proposal types will not be considered at this time:
・Pediatric OAB and NDO. 
・General OAB disease research e.g., epidemiology, diagnosis and treatment, biomarkers, etc.
・Alternate mirabegron dosing, head-head comparisons to vibegron and small safety-only studies, CV outcomes.
・Combination treatment with mirabegron e.g., botulinum toxin A (Botox), neuromodulation, etc.