80O: Patient (pt) preference and satisfaction with the subcutaneous - PowerPoint PPT Presentation

80O: Patient (pt) preference and satisfaction with the subcutaneous fixed-dose combination of pertuzumab (P) and trastuzumab (H) in pts with HER2-positive early breast cancer (HER2+ eBC): Interim analysis of the open-label, randomised cross-over PHranceSCa study Joyce O'Shaughnessy, 1 Susana Sousa, 2 Josefina Cruz, 3 Lesley Fallowfield, 4 Päivi Auvinen, 5 Catarina Pulido, 6 Ana Cvetanovic, 7 Sharon Wilks, 8 Leonor Ribeiro, 9 Mauricio Burotto, 10 Dirk Klingbiel, 11 Dimitri Messeri, 11 Ari Alexandrou, 12 Peter Trask, 13 Judy Fredriksson, 11 Ljiljana Stamatovic 14 1 Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX, USA ; 2 Department of Medical Oncology, Portuguese Oncology Institute of Porto, Porto, Portugal; 3 Hospital Universitario de Canarias, La Laguna, S/C Tenerife, Spain; 4 Brighton & Sussex Medical School, Falmer, UK; 5 Cancer Center, Kuopio University Hospital, Kuopio, Finland; 6 Centro de Oncologia, Hospital Da Luz Lisboa, Lisbon, Portugal; 7 Medical Faculty Nis and Clinical Centre Nis, Nis, Serbia; 8 Texas Oncology San A ; 9 Centro Hospitalar Universitário Lisboa Norte/Hospital Santa Maria ntonio, San A ntonio, TX, USA (CHULN/HSM), Lisbon, Portugal; 10 Bradford Hill Clinical Research Center, Santiago, Chile; 11 F. Hoffmann-La Roche Ltd, Basel, Switzerland; 12 Roche Products Limited, Welwyn Garden City, UK; 13 Genentech, Inc., South San Francisco, CA , USA ; 14 Clinic for Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia esmo.org Access slides at: https://bit.ly/2Vqn13i

Disclosures JO’S reports consultancy/advisory roles for AbbVie, Agendia, Amgen, AstraZeneca, BMS, Celgene, Eisai, Genentech, Inc., Immunomedics, Ipsen, Lilly, Merck, Novartis, Odonate, Pfizer, Puma, Prime Oncology, F. Hoffmann-La Roche Ltd, Seattle Genetics and Daiichi Sankyo. SS reports funding for travelling, congresses, lectures and advisory boards from F. Hoffmann-La Roche Ltd, Novartis, Pfizer, Tesaro, AstraZeneca, MSD, Pierre Fabre and Eisai. JC reports speaker honoraria from GSK, AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, Pharmamar, Eisai, Lilly, Celgene, Astellas, Amgen and Pfizer, and consultant/advisory roles for GSK, AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, Pharmamar, Eisai, Lilly, Celgene, Astellas, Amgen and Pfizer. LF reports honoraria from Pfizer, AstraZeneca, BMS, Lilly, Novartis, Genomic Health and Nanostring. CP reports public speaking for AstraZeneca, Grunenthal and Novartis, and writing engagements from AstraZeneca. SW reports payment for an advisory board from Seattle Genetics. LR reports payments for speaking and advisory boards from Roche Pharmaceuticals, Merck Serono, MSD, BMS, AstraZeneca and Pfizer, and for personal medical education and participation in congresses from BMS, Roche Pharmaceuticals, Merck Serono, Pfizer, Amgen and Pierre Fabre. MB reports payments for advisory boards, speaking at industry symposiums and consulting roles from F. Hoffmann-La Roche Ltd, MSD, BMS, AstraZeneca and Novartis. DK is an employee of, and owns stocks in, F. Hoffmann-La Roche Ltd. DM is an employee of F. Hoffmann-La Roche Ltd. AA is an employee of Roche Products Limited. PT is an employee of, and owns stocks in, Genentech, Inc. JF is an employee of F. Hoffmann-La Roche Ltd. All authors have received support for third-party writing assistance for this presentation, furnished by Daniel Clyde, PhD, of Health Interactions, from F. Hoffmann-La Roche Ltd. Funding for this study was provided by F. Hoffmann-La Roche Ltd. Access slides at: https://bit.ly/2Vqn13i

PH FDC SC combines P + H in one ready-to-use, fixed-dose combination vial for SC injection Administration is less invasive and more rapid vs separate P + H IV infusions 1–3  Loading doses (max)* P + H IV 150 420 PH FDC SC 8 30 Maintenance doses (max)* P + H IV infusion PH FDC SC administration P + H IV 90 180 Observation time PH FDC SC 5 15 0 40 80 120 160 200 240 280 320 360 400 440 480 520 560 600 Time (minutes) PH FDC SC can potentially reduce patients’ time in the clinic and free up resources at the practice  PROs are increasingly important for decision-making; PHranceSCa provides insights into patients’  perspectives on PH FDC SC and provides supportive information to the pivotal FeDeriCa PK study 1 P IV and H IV can be given in any order. The PH FDC SC maintenance dose observation period assumes that the loading dose injection is well tolerated; patients can be observed for longer at the discretion of the investigator, per local requirements. Administration/observation times vary according to local labels. * P IV loading dose if needed: 840 mg; maintenance: 420 mg. H IV loading dose if needed: 8 mg/kg; maintenance: 6 mg/kg. PH FDC SC loading dose if needed: P 1200 mg/H 600 mg in 15 mL; maintenance: P 600 mg/H 600 mg in 10 mL. 1. Tan A, et al . SABCS 2019 (Abstract PD4-07); 2. Herceptin SmPC 2019; 3. PERJETA SmPC 2019. H, trastuzumab; IV, intravenous; P, pertuzumab; PH FDC SC, pertuzumab–trastuzumab fixed-dose combination for subcutaneous use; PK, pharmacokinetic; PROs, patient-reported outcomes. Access slides at: https://bit.ly/2Vqn13i

PHranceSCa is an open-label, randomised cross-over study evaluating patient preference for PH FDC SC vs PH IV (NCT03674112) Cross-over period Continuation period F P + H lV* PH FDC SC † O x 3 cycles x 3 cycles L HER2-positive eBC; Patient selected L completed neoadjuvant R PH FDC SC or P + H IV O 1:1 P + H + chemo + surgery for a total of 18 cycles W Target N = 140 P + H lV* PH FDC SC † - x 3 cycles x 3 cycles U P D1C3 D1C6 TASQ PPQ, TASQ Stratification factors: Primary objective: Patient preference for PH FDC SC • NACT regimen Key secondary objectives: Patient satisfaction; patients’ choice of formulation for the continuation period; • pCR vs non-pCR HRQoL, HCP perception on time/resource, safety and tolerability (including safety of switching from SC to IV • HR status formulations and vice-versa), efficacy All patients were female; median age was 49 years. Adjuvant hormone therapy and radiotherapy for breast cancer were permitted. * P IV loading dose if needed: 840 mg; maintenance: 420 mg q3w. H IV loading dose if needed: 8 mg/kg; maintenance: 6 mg/kg IV q3w. † PH FDC SC loading dose if needed: P 1200 mg/H 600 mg in 15 mL; maintenance: P 600 mg/H 600 mg in 10 mL q3w. Loading doses were only required for patients who had ≥6 weeks since their last neoadjuvant dose of P + H IV at study entry, or had ≥6 weeks since their last study treatment during the study. Maintenance doseswere used for subsequent administrations or dose delays <6 weeks. eBC, early breast cancer; chemo, chemotherapy; H, trastuzumab; HCP, healthcare professional; HR, hormone receptor; HRQoL, health-related quality of life; IV, intravenous; NACT, neoadjuvant chemotherapy; P, pertuzumab; pCR, pathological complete response; PH FDC SC, pertuzumab–trastuzumab fixed-dose combination for subcutaneous use; PPQ, Patient Preference Questionnaire; q3w, every 3 weeks; SC, subcutaneous; TASQ, Therapy Administration Satisfaction Questionnaire. Access slides at: https://bit.ly/2Vqn13i

At IA, >80% of patients preferred PH FDC SC regardless of sequencing PPQ Q1: “All things considered, which method of administration did you prefer?” Preferred SC Preferred IV • PPQ completion rate: 100% 100 • Main reasons for SC preference: 90 84 82 81 • “Less time in clinic 80 (38/86 responses; 44%)” 70 Patients (%) • “More comfortable 60 during administration 50 (22/86 responses; 26%)” 40 • Results consistent with PrefHer 1 30 • PPQ findings consistent with 19 18 16 20 treatment continuation choice: 10 84% PH FDC vs 16% P + H IV 0 All patients P + H IV→ PH FDC SC→ (n = 51)* PH FDC SC P + H IV Clinical cut-off: 19 August, 2019. (n = 26) (n = 25) 95% CI for PH FDC SC preference: 60.7–93.5; 63.9–95.5; 69.1–91.6, respectively. 1. Pivot X, et al . Ann Oncol 2014; 25: 1979–1987. * 118 patients randomised; 51 completed the cross-over period and had made their treatment continuation choice. CI, confidence interval; H, trastuzumab; IA, Interim analysis; IV, intravenous; P, pertuzumab; PH FDC SC, pertuzumab–trastuzumab fixed-dose combination for subcutaneous use; PPQ, Patient Preference Questionnaire; Q, question; SC, subcutaneous. Access slides at: https://bit.ly/2Vqn13i

TASQ responses supportive of primary endpoint: 90% of patients were “very satisfied” or “satisfied” with PH FDC SC vs 67% with P + H IV at IA TASQ Q1: “ How satisfied or dissatisfied were you with the SC injection/IV infusion? ” TASQ-SC TASQ-IV 100 100 90 90 76 80 80 70 70 63 Patients (%) Patients (%) 60 60 50 50 50 42 41 40 40 35 40 40 31 31 27 25 30 30 24 23 15 16 20 20 8 10 4 10 4 2 2 0 0 0 0 0 0 0 0 0 0 0 All patients All patients P + H IV→ PH FDC SC→ P + H IV→ PH FDC SC→ PH FDC SC P + H IV (n = 51) PH FDC SC P + H IV (n = 51) (n = 26) (n = 25) (n = 26) (n = 25) Very satisfied Satisfied Neither satisfied nor dissatisfied Dissatisfied Very dissatisfied H, trastuzumab; IA, interim analysis; IV, intravenous; P, pertuzumab; PH FDC SC, pertuzumab–trastuzumab fixed-dose combination for subcutaneous use; Q, question; SC, subcutaneous; TASQ, Therapy Administration Satisfaction Questionnaire. Access slides at: https://bit.ly/2Vqn13i