Which Treatment Approach is Most Appropriate for Primary Therapy of Gastric Cancer: Neoadjuvant Chemotherapy

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1 Which Treatment Approach is Most Appropriate for Primary Therapy of Gastric Cancer: Neoadjuvant Chemotherapy Joseph Chao, M.D. Assistant Clinical Professor Department of Medical Oncology & Therapeutics Research November 12 th, 2016

2 Disclosures Description of off-label use of the following agents: bevacizumab, trastuzumab, pertuzumab Research Support: Merck Advisory Boards: Five Prime Therapeutics, Lilly

3 How Did We Get Here?

4 Adjuvant Therapy SWOG/INT-0116 Macdonald Regimen Japanese ACTS-GC D0 54% D1 36% D2 9.6% D1 0.1% D2 94% D3 6% Smalley, SR et al. JCO Sakuramoto S, et al. NEJM. 2007

5 Perioperative Chemotherapy MAGIC Epirubicin, Cisplatin, Fluorouracil FFCD 9703 Cisplatin, Fluorouracil 86% of patients assigned to chemotherapy completed all 3 neoadjuvant cycles 42% of all patients assigned to chemotherapy received all 6 cycles 87% of patients assigned to chemotherapy completed at least 2 cycles 48% of patients assigned to chemotherapy received adjuvant cycles Cunningham D, et al. NEJM Ychou M, et al. JCO. 2011

6 More Adjuvant Therapy (After a D2 Surgery) Asian CLASSIC Trial Asian ARTIST Trial Noh SH, et al. Lancet Onc Park SH, et al. JCO. 2015

7 ChemoRadiotherapy after Induction chemotherapy In Cancer of the Stomach Dutch CRITICS Trial What is the role of adjuvant chemoradiation after patients have received neoadjuvant chemotherapy?

8 Dutch CRITICS Trial Treatment Adherence Verheij M, et al. ASCO 2016 Abstr 4000

9 Dutch CRITICS Trial Surgical Outcomes Verheij M, et al. ASCO 2016 Abstr 4000

10 Dutch CRITICS Trial Toxicities with Post-Op Therapy Verheij M, et al. ASCO 2016 Abstr 4000

11 Dutch CRITICS Trial Overall Survival Results No difference between adjuvant CRT vs. CT 5-yr survival 40.9% vs. 40.8% Median OS 3.3 vs. 3.5 yrs 50% adherence to adjuvant therapy, should efforts focus on neoadjuvant therapy? Verheij M, et al. ASCO 2016 Abstr 4000

12 UK MRC OE05 Trial Neoadjuvant ECX vs. CF Are 3 drug combinations better than 2 drug combinations for perioperative chemotherapy? Cunningham D, et al. ASCO 2015 Abstr 4002

13 OE05 Chemotherapy Toxicity Cunningham D, et al. ASCO 2015 Abstr 4002

14 OE05 Pathologic Responses Cunningham D, et al. ASCO 2015 Abstr 4002

15 OE05 Progression-Free Survival Median PFS (95% CI) CF 1.53 yrs (1.29, 2.74) ECX 1.78 yrs (1.61, 2.00) HR 0.86 (95% CI, 0.74, 1.01) p = Cunningham D, et al. ASCO 2015 Abstr 4002

16 OE05 Overall Survival Median OS (95% CI) CF 2.02 yrs (1.80, 2.38) ECX 2.15 yrs (1.93, 2.53) HR 0.92 (95% CI, 0.79, 1.08) p = Cunningham D, et al. ASCO 2015 Abstr 4002

17 ST-03 Trial (MAGIC-B) Perioperative Bevacizumab Can the addition of biologics improve perioperative chemotherapy? Cunningham D, et al. ESMO/ECC 2015 Abstr 2201

18 ST-03 Trial (MAGIC-B) Baseline Characteristics Cunningham D, et al. ESMO/ECC 2015 Abstr 2201

19 ST-03 Trial (MAGIC-B) Chemotherapy Delivery Cunningham D, et al. ESMO/ECC 2015 Abstr 2201

20 ST-03 Trial (MAGIC-B) Toxicities Cunningham D, et al. ESMO/ECC 2015 Abstr 2201

21 ST-03 Trial (MAGIC-B) Surgical Outcomes Cunningham D, et al. ESMO/ECC 2015 Abstr 2201

22 ST-03 Trial (MAGIC-B) Overall Survival Cunningham D, et al. ESMO/ECC 2015 Abstr 2201

23 ST-03 Trial (MAGIC-B) Overall Survival Cunningham D, et al. ESMO/ECC 2015 Abstr 2201

24 Ongoing Trials

25 Australian TOPGEAR Study What is the role of neoadjuvant chemoradiation for patients receiving perioperative chemotherapy? Enrollment: Resectable gastric or GEJ adenocarcinoma ECF x 3 cycles Surgery ECF x 3 cycles ECF x 2 cycles 45 Gy RT/5-FU Surgery ECF x 3 cycles

26 ARTIST II Trial After D2 resection for patients with lymph node metastases is adjuvant chemoradiation beneficial? Does oxaliplatin provide additional benefit in node positive disease? S-1 (q6 weeks) x 8 cycles Enrollment: D2 Resected Gastric or GEJ adenocarcinoma, N+ S-1 + oxaliplatin (q3 weeks) x 8 cycles S-1 + oxaliplatin x 2 cycles 45 Gy RT/S-1 S-1 + oxaliplatin x 4 cycles

27 INtegratioN of Trastuzumab Into perioperative chemotherapy of HER2 positive stomach cancer INNOVATION Trial Does the addition of trastuzumab ± pertuzumab increase pathologic complete response rate in HER2-overexpressing gastric cancer? CF or CX Surgery Enrollment: Resectable Gastric or GEJ adenocarcinoma, HER2+ CF or CX + trastuzumab Surgery CF or CX + trastuzumab + pertuzumab Surgery

28 MAGIC-B (ST03) Trial HER2 Overexpressing Subset Does the addition of lapatinib in HER2-overexpressing tumors provide additional benefit to perioperative chemotherapy? ECX x 3 cycles Surgery ECX x 3 cycles Enrollment: Resectable Gastric or GEJ adenocarcinoma ECX + bevacizumab x 3 cycles Surgery ECX + bevacizumab x 3 cycles bevacizumab x 6 cycles ECX + lapatinib x 3 cycles Surgery ECX + lapatinib x 3 cycles lapatinib x 6 cycles (HER2+)

29 The Cancer Genome Atlas (TCGA) 295 Primary Gastric Adenocarcinomas TCGA. Nature 2014; 513:

30 The Cancer Genome Atlas (TCGA) 295 Primary Gastric Adenocarcinomas TCGA. Nature 2014; 513:

31 Precision Medicine Anatomic and Genomic Characterization

32 Summary Two drug approaches now appear more favorable over three drug approaches for neoadjuvant/perioperative chemotherapy If neoadjuvant chemotherapy is given, continuation of adjuvant chemotherapy after surgery without radiation remains standard of care Targeted therapies/biologic agents have not yet entered standard of practice For all stages of disease continued investigation needs to be performed to discover predictive biomarkers to optimize currently available and future therapies

33

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