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(1)

Innovazione e

personalizzazione: come i nuovi farmaci cambiano la

strategia terapeutica

Carcinoma del Pancreas

Coinu Andrea

UO Oncologia Ospedale San Francesco

Nuoro

(2)

Agenda

News on Neoadjuvant treatment

Adjuvant Landscape

Biomarker-driven Approach in advanced pancreatic cancer?

Immunotherapy?

(3)

Neoadjuvant Treatment

(4)

Neoadjuvant Treatment

(5)

Neoadjuvant Treatment

(6)

Neoadjuvant Treatment

(7)

Neoadjuvant Treatment

(8)

Neoadjuvant Treatment

(9)

Neoadjuvant Treatment

(10)

Adjuvant Landscape - FOLFIRINOX

(11)

Adjuvant Landscape - FOLFIRINOX

(12)

Adjuvant Landscape - FOLFIRINOX

(13)

Adjuvant Landscape - FOLFIRINOX

(14)

Adjuvant Landscape - FOLFIRINOX

(15)

Adjuvant Landscape - FOLFIRINOX

(16)

Adjuvant Landscape - FOLFIRINOX

(17)

Adjuvant Landscape

• mFOLFIRINOX should be the first adjuvant therapeutic option after resection of pancreatic cancer in selected and fit patients, in view of survival outcomes and associated toxicity profile (ESMO and NCCN Guidelines update – March/May 2019)

• In more frail patients (age > 70, Eastern Cooperative Oncology Group performance status 2, or patients who have any

contraindication to the drugs used in FOLFIRINOX), gemcitabine/capecitabine could be an option

• Gemcitabine alone should be used only in frail patients

(18)

Abstract 4000

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(19)

Study design

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(20)

Primary endpoint:<br />Independently assessed dfs (ITT population)

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(21)

Prespecified subgroup analysis: <br />independently assessed dfs (itt population)

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(22)

prespecified sensitivity analysis: <br />investigator assessed Dfs (itt Population)

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(23)

Secondary endpoint:<br />Interim os (Itt population)

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(24)

Safety (treated population)

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(25)

Conclusions

Presented By Margaret Tempero at 2019 ASCO Annual Meeting

(26)

Olaparib as maintenance treatment following <br />first-line platinum-based chemotherapy in patients with a germline BRCA mutation and metastatic pancreatic cancer: Phase III POLO trial

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(27)

Rationale for PARP inhibition in BRCA-deficient tumors

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(28)

Study design

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(29)

Study endpoints

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(30)

Primary endpoint: PFS by blinded<br />independent central review*

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(31)

PFS at prespecified timepoints by blinded <br />independent central review*

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(32)

Subgroup analyses of PFS*

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(33)

OS: interim analysis, 46% maturity*

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(34)

PFS2 by investigator assessment: <br />interim analysis, 46% maturity*

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(35)

Objective response* in patients with measurable disease <br />by blinded independent central review<br />

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(36)

Patient-Reported Global HRQoL (EORTC QLQ-C30)

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(37)

Safety summary: AEs and exposure

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(38)

Most common AEs<br />

Presented By Hedy Kindler at 2019 ASCO Annual Meeting

(39)

39

Immunotherapy – AACR 2019

Phase Ib trial

cd40 agonist (APX005M) +/- Nivolumab + Gem/NB Treatment-naive pts (n=30)

Safety : only 2 grade 3-4 Aes (Febrile neutropenia)

RR = 46.7%

Duration of Response for some pts lasting more than

10 months

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