PERJETA + Herceptin + docetaxel nearly doubled pCR rates vs Herceptin-- NeoSphere

[Lani]

trial results summary



Patients with HER2+ early stage breast cancer may benefit from PERJETA-based therapy prior to surgery

Patient eligibility for preoperative therapy with PERJETA1

HER2+ status and at least one of the following:

Tumor(s) >2 cm

Node+

Inflammatory breast cancer

The outcome of preoperative systemic therapy is assessed by pathological complete response (pCR)

PERJETA + Herceptin + docetaxel nearly doubled pCR rates vs Herceptin + docetaxel in the NeoSphere trial

pCR rate in breast and nodes (FDA-preferred endpoint)

• PERJETA + Herceptin (n=107): 11.2% pCR (95% CI: 5.9-18.8; P=0.0223) vs Herceptin + docetaxel

• PERJETA + docetaxel (n=96): 17.7% pCR (95% CI: 10.7-26.8; P=0.0018) vs PERJETA + Herceptin + docetaxel

Results of the phase II randomized NeoSphere trial (referred to as Study 2 in the PERJETA prescribing information). Treatment cycles were received every 3 weeks. During the neoadjuvant period, all patients received 4 cycles of their respective therapies. PERJETA dosing: 840 mg loading dose, 420 mg for subsequent cycles; Herceptin dosing: 8 mg/kg loading dose, 6 mg/kg for subsequent cycles (administered to complete 1 year of treatment); docetaxel dosing: 75 mg/m2 each cycle, escalated to 100 mg/m2 at investigator’s discretion if initial dose was well tolerated. Patients in the PERJETA + Herceptin neoadjuvant arm received 4 cycles of docetaxel + Herceptin as adjuvant therapy. pCR in breast was the primary endpoint studied in the NeoSphere trial.