Highlights

(1)

Nicola Silvestris

[email protected] [email protected]

(2)

FINANCIAL SUPPORT Sponsor None

DISCLOSURES

(3)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062



PDAC

 APACT

 POLO



BTC

 ABC-06



HCC

 SURF

 KEYNOTE-240

(4)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062

 PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

(5)

(6)

(7)

ARTIST 2 Primary Endpoint

(8)

ARTIST 2 Subgroup Analysis of DFS

(9)

Conclusions

(10)

PRESENTED BY: Josep Tabernero

(11)

Baseline Characteristics (CPS ≥1)

(12)

KEYNOTE-062: P vs C

(13)

Overall Survival: P vs C (CPS ≥1)

(14)

Response Summary: P vs C

(15)

(16)

KEYNOTE-062: P+C vs C

(17)

Overall Survival: P+C vs C (CPS ≥1)

(18)

Progression-Free Survival: P+C vs C

(19)

Response Summary: P+C vs C

(20)

Summary: P+C vs C

(21)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062

 PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

Adjuvant SOX or SOXRT vs S-1: DFS; no additional benefit with CTRT vs S-1/SOX

First-line P vs CT: similar benefit in OS for CPS≥1 and favorable effect for CPS ≥10;

better tolerability profile for P; modest additional benefit of P+CT vs CT

(22)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062



PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

(23)

PRESENTED BY: Margaret Tempero

• Primary endopint:

independently assessed DFS

• Secondary endpoints:

OS, safety

• Exploratory endpoints:

tumor and blood analysis, QoL

• Prespecified sensitivity analyses:

investigator-assessed DFS

(24)

(25)

PRIMARY ENDPOINT:

INDEPENDENTLY ASSESSED DFS (ITT POPULATION)

PRESPECIFIED SENSITIVITY ANALYSIS:

INVESTIGATOR ASSESSED DFS

(26)

SECONDARY ENDPOINTS: INTERIM OS, SAFETY

(27)

CONCLUSIONS (APACT)

(28)

PRESENTED BY: Hedy L Kindler

(29)

STUDY ENDPOINTS

(30)

(31)

(32)

(33)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062



PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

Adjuvant Gem+Abraxane vs Gem: indipendently assessed DFS was not met;

modest additional benefit in interim OS for Gem+Abraxane

Maintance olaparib improved PFS in BRCAm metastatic PDAC whose disease had not progressed durimg platinum-based CT

(34)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062



PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

(35)

PRESENTED BY: Angela Lamarca

(36)

(37)

(38)

(39)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062



PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

mFOLFOX + ASC: standard of care in second-line

(40)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062



PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

(41)

PRESENTED BY: Namiki Izumi

 PRIMARY ENDPOINTS:

• RFS; OS

 SECONDARY ENDPOINTS:

• Liver function 1, 3, 5 years after

• Pattern of first recurrence; SAE

(42)

PRESENTED BY: Namiki Izumi

RFS (years, median)

Surgery 2.98 (2.33-3.86)

RFA 2.76 (2.17-3.80) p=0.793 (0.72-1.28)

(43)

PRESENTED BY: Richard S. Finn

• Primary endopoints:

 OS; PFS

• Seconday endopoints :

 ORR, DOR, DCR and TTP

 safety

(44)

Statistical Considerations

(45)

These differences did not meet significance per the prespecified statistical plan

(46)

Summary

(47)



Esophageal and gastric cancer

 ARTIST 2

 KEYNOTE-062



PDAC

 APACT

 POLO

 BTC

 ABC-06

 HCC

 SURF

 KEYNOTE-240

First-line Pembro vs CT: similar benefit in OS for CPS≥1 and favorable effect for CPS ≥10; better tolerability profile for P; modest additional benefit of P+CT vs CT

Surgery vs RFA: no differences in RFS for HCC <3 cm

Pembro vs PLB: statistical criteria for OS and PFS were not meet

Thanks!

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