1. IMagyn050 YO39523/GOG-3015/ENGOT-ov39 Recruitment Update
12 Jan 2018

2. Study Design in Primary Surgery Cohort
Carboplatin AUC 6 q3wk
Previously untreated ovarian, fallopian tube, or peritoneal cancer
Post-operative Stage III w/macroscopic residual disease, Stage IV
ECOG PS 0-2
Paclitaxel 175 mg/m2 q3wk
Bev 15 mg/kg q3wk
R 1:1
Bev 15 mg/kg X 16 cycles
Placebo q3w X 22 cycles
No cross-over
Carboplatin AUC 6 q3wk
Stratification variables
Stage/debulking status
ECOG PS
PDL1 IC0 vs IC1+
Adjuvant/Neo-adjuvant
Paclitaxel 175 mg/m2 q3wk
Key points:
Patient population are those NOT R0 (Stage 3 & Stage 4)
ECOG PS 2 is allowed
Bev starts Cycle 2
22 cycle duration is modeled after pivotal Phase 3 bev study (GOG218)
Carbo AUC 6, not 5
Must be q3w Taxol, not ddTaxol (based on GOG262)
PDL1 testing & results are for statistical purposes only. Results don’t gate entry into the study.
Bev 15 mg/kg q3wk
Bev 15 mg/kg X 16 cycles
Atezo 1200 mg q3w X 22 cycles

3. Study Design in Neoadjuvant Cohort
Previously untreated ovarian, fallopian tube, or peritoneal cancer
Stage III / IV, Unresectable advanced stage patients for neoadjuvant therapy
ECOG PS 0-2
R 1:1
Carboplatin AUC 6
Bev 15 mg/kg X 16 cycles
Placebo q3w X 22 cycles
Paclitaxel 175 mg/m2
Bev 15 mg/kg
Atezo 1200 mg q3w X 22 cycles
No cross-over
SURGERY
Key Points:
Reason for NACT must be disease-related (e.g., location/bulk of disease making patient unresectable to R0), based on Fagotti
Interval surgery must be b/w C3 & D4
No bev C3 & C4 b/c of surgery

4. IMagyn050: Study Outcome Measures Efficacy
SEE PROTOCOL SECTION 6.4
Co-Primary
PFS time from randomization to PD or death from any cause, whichever occurs first
ITT population
PDL1+ population
OS time from randomization to death from any cause
Key Points
Survival follow-up (OS) continues after Study drug discontinuation and after Progression/Recurrence (PFS) Including:
After progression
After AE-related treatment discontinuation
After stopping Study drug for any reason
After starting a new regimen upon progression
Documentation:
Patient discontinued from Study treatment

5. IMagyn050: Study Outcome Measures Efficacy
SEE PROTOCOL SECTION 6.4
Secondary
Objective Response (Primary Surgery patients): PR* or CR* in pts with measurable residual disease after primary surgery
Duration of Response (Primary Surgery patients): time between first occurrence of CR/PR to time of PD* or death from any cause, whichever comes first
Patient-reported Ovarian Cancer Abdominal Symptoms (Neoadjuvant patients): proportion of pts in each arm reporting clinically meaningful improvement in PR-abdominal pain/bloating (≥10 pt decrease from baseline score, EORTC QLQ-OV28)
Patient-reported function & HRQoL: (1) Proportion of neoadjuvant pts in each arm reporting clinically meaningful in PR-function & HRQoL (≥10 pt decrease from baseline score, EORTC QLQ-C30); (2) (1) Proportion of primary surgery pts in each arm reporting improving, stable, or worsening PR-function & HRQoL
Key points:
Key Secondary Endpoint ORR & DOR are for primary surgery patients who have measureable disease; therefore, since measureable disease is not required for entry into the study, this will be a fraction of those patients who are in the primary surgery group, not all of them
Abdominal symptoms: We are testing the hypothesis that there will be a greater proportion of pts getting a more efficacious NACT regimen reporting greater abdominal symptomatic relief compared to pts who aren’t getting the more efficacious regimen

6. IMagyn050 Recruitment Summary (as of 12 Jan 2018)

7. IMagyn050 Countries Summary (as of 12 Jan 2018)
Site Activation
Planned Actual
Recruitment
Planned Actual
Australia 3 15 8
Austria 4 10 1
Belgium 38
Brazil 2 7
China 16
150 9
Czech Republic 5 17
Denmark 13
Finland
France 39
Germany 20 65
Greece 37
Israel
Italy 77
Japan
120 31
Norway 11
Poland 6
Russian Federation 33
South Korea
Spain 35
Sweden
Turkey
USA 99 83
550
106
Region / Community
Total Recruitment
Planned Actual % of Goal
GOG (US)
550
106
19.3%
ENGOT (EU)
420 23
5.5%
Chugai(Japan)
120 31
25.8%
China
150 9
6.0%
ROW 60 63
105.0%

8. Participating sites MITO

9. Participating sites MaNGO