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Updates in Hepatobiliary and Pancreatic Cancer

Updates in Hepatobiliary and Pancreatic Cancer. Disclosers. None. Abstracts to be discussed. Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial

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Updates in Hepatobiliary and Pancreatic Cancer

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  1. Updates in Hepatobiliary and Pancreatic Cancer

  2. Disclosers None

  3. Abstracts to be discussed Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial APACT: phase III, multicenter, international, open-label, randomized trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) for surgically resected pancreatic adenocarcinoma. KEYNOTE-240: phase 3 study of pembrolizumab (Pembro) vs best supportive care (BSC) for second line therapy in advanced hepatocellular carcinoma (HCC) Randomized, open-label, perioperative phase II study evaluating nivolumab alone versus nivolumab plus ipilimumab in patients with resectable HCC Efficacy and safety of dabrafenib (D) and trametinib (T) in patients (pts) with BRAF V600E–mutated biliary tract cancer (BTC): A cohort of the ROAR basket trial ABC-06 | A randomized phase III, multi-center, open-label study of Active Symptom Control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy.

  4. Pancreatic Cancer

  5. Summary Germline testing for all pancreatic cancers patients should be considered at diagnosis Maintenance olaparib provided a statistically significant and clinically meaningful improvement in progression-free survival to patients with a germline BRCA mutation and metastatic pancreatic cancer whose disease had not progressed during platinum-based chemotherapy Interim survival data showed no difference between arms. We are still awaiting final survival results Maintenance olaparib was well-tolerated with an AE profile similar to that seen in other tumors First-line platinum-based chemotherapy followed by maintenance olaparib treatment should become the new standard of care for patients with metastatic pancreatic cancer who have a germline BRCA mutation

  6. Abstract 4000 Presented By Margaret Tempero at 2019 ASCO Annual Meeting

  7. introduction Presented By Margaret Tempero at 2019 ASCO Annual Meeting

  8. Study design Presented By Margaret Tempero at 2019 ASCO Annual Meeting

  9. Primary endpoint:<br />Independently assessed dfs (ITT population) Presented By Margaret Tempero at 2019 ASCO Annual Meeting

  10. Prespecified subgroup analysis: <br />independently assessed dfs (itt population) Presented By Margaret Tempero at 2019 ASCO Annual Meeting

  11. prespecified sensitivity analysis: <br />investigator assessed Dfs (itt Population) Presented By Margaret Tempero at 2019 ASCO Annual Meeting

  12. Prespecified subgroup analysis: <br />OS (itt population) Presented By Margaret Tempero at 2019 ASCO Annual Meeting

  13. Summary • The primary endpoint of independently assessed disease-free survival was not met • Investigator-assessed disease-free survival appears to align more closely with the overall survival results • Overall survival is encouraging, and longer follow-up will clarify the role for this combination as adjuvant therapy for pancreatic adenocarcinoma • Interim analysis suggests that continued investigation of this regimen in patients with lymph-node positive disease, R1 resection, or inability to tolerate modified FOLFIRINOX is warranted.

  14. Hepatobiliary Cancer

  15. Results of KEYNOTE-240: <br />Phase 3 Study of Pembrolizumab vs Best Supportive Care for Second-Line Therapy in Advanced Hepatocellular Carcinoma Presented By Richard Finn at 2019 ASCO Annual Meeting

  16. KEYNOTE-240 Study Design Presented By Richard Finn at 2019 ASCO Annual Meeting

  17. Overall Survival Presented By Richard Finn at 2019 ASCO Annual Meeting

  18. Progression-Free Survival Presented By Richard Finn at 2019 ASCO Annual Meeting

  19. Objective Response Rate at Final Analysis<br />(RECIST 1.1, BICR) Presented By Richard Finn at 2019 ASCO Annual Meeting

  20. Post-study Anticancer Therapy Presented By Richard Finn at 2019 ASCO Annual Meeting

  21. Summary • Pembrolizumab reduced the risk of death by 22% • Improved PFS over placebo in patients with advanced liver cancer. Hazard ratio of 0.781 for OS and 0.718 for PFS. (However, these data did not reach the pre-specified efficacy boundaries) • Overall response rate was higher with pembrolizumab. these responses were durable. • Safety of pembrolizumab in this population of patients in the second line was very consistent to what was seen in the phase II studies • This study did not meet the statistical criteria set out for either OS or PFS. The magnitude of benefit is captured by the hazard ratios for OS, PFS. Response rate, duration of response are consistent with what was seen in KEYNOTE-224

  22. Randomized, Open-Label, Perioperative Phase II Study Evaluating Nivolumab Alone versus Nivolumab plus Ipilimumab in Patients with Resectable HCC Presented By Ahmed Kaseb at 2019 Gastrointestinal Cancer Symposium

  23. Study Design Presented By Ahmed Kaseb at 2019 Gastrointestinal Cancer Symposium

  24. First Interim Analysis Presented By Ahmed Kaseb at 2019 Gastrointestinal Cancer Symposium

  25. Correlative Studies Presented By Ahmed Kaseb at 2019 Gastrointestinal Cancer Symposium

  26. Efficacy and Safety of Dabrafenib + Trametinib in Patients With BRAF V600E–Mutated Biliary Tract Cancer: A Cohort of the ROAR Basket Trial Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  27. Background Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  28. Genetic Targets in BTC Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  29. ROAR: A Phase 2, Open-Label, Multicenter Study (NCT02034110) Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  30. Best Overall Response Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  31. Investigator-Assessed Maximum Reduction in SLD of Target Lesions Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  32. Duration of Treatment Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  33. PFS and OS in the ITT/Evaluable Population Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

  34. Summary of AEs Including Any-Cause, Treatment-Related, Serious, and Treatment-Altering AEs Presented By Zev Wainberg at 2019 Gastrointestinal Cancer Symposium

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