Pertuzumab and codrituzumab Dual-target Neoadjuvant PEONY Study of HER2-positive Breast Cancer

SABCS is the world's largest and most influential breast cancer conference. Since 1977, it has developed into a five-day seminar with more than 7,000 scientific researchers and doctor representatives from more than 90 countries around the world. At this year's SABCS, the Phase III PEONY study of Pertuzumab + codrituzumab dual-targeted neoadjuvant treatment of HER2-positive breast cancer in the Asian population led by Professor Shao Zhimin will show the results of the first analysis.

In 2012, Lancet Oncol published a NeoSphere Phase II study to evaluate the efficacy and safety of neoadjuvant therapy for codrituzumab + pertuzumab combined with docetaxel in patients with locally advanced, inflammatory or early HER2-positive breast cancer Sex. NeoSphere study results showed that patients who received pertuzumab and codrituzumab plus docetaxel had significantly higher pathological complete remission rate than patients who received codrituzumab plus docetaxel, bpCR (45.8 % vs29%, P = 0.0141), tpCR (39.3% vs 21.5%). There was no significant difference in tolerance. Then the 5-year data analysis of the NeoSphere study was published in 2016 by Lancet Oncol, and the results show that the triple target of Qupa can bring the benefits of PFS (86% vs 81%). Regardless of PFS or DFS, combined dual-targeted neoadjuvant therapy is superior to other groups. This is because Pertuzumab and codrituzumab exhibit complementary mechanisms of action in the anticancer activity of HER2-positive breast cancer patients. The combined application of the two blocks the formation of homo- and heterodimers by acting on different extracellular domains of the HER-2 protein, thereby blocking its downstream signaling and inhibiting tumor cell proliferation; at the same time, the ADCC effects of the two superimpose, It has a synergistic effect and activates immune NK cells to completely eliminate tumor cells.

Due to differences in race, region, lifestyle, etc., the Asian population is different from the Western population. Can the NeoSphere research results be applicable to Asian populations? Under the leadership of Professor Shao Zhimin Shao, PEONY research was conducted jointly with many centers from mainland China and Taiwan, South Korea and Thailand.

PEONY (NCT02586025) is a randomized, multicenter, double-blind, placebo-controlled phase III trial of Asian populations (Mainland China, Taiwan, South Korea, Thailand). The main comparison is Pertuzumab in neoadjuvant Differences in efficacy, safety, and tolerability between the anti-codrituzumab + docetaxel regimen and the placebo + codrituzumab + docetaxel regimen. This study enrolled early (T2–3, N0–1) / locally advanced (T2–3, N2 or N3; T4, any N) breast cancer patients who had confirmed HER2-positive, randomized in a 2: 1 ratio before surgery Enter Pertuzumab + codrituzumab + Docetaxel regimen group or Placebo + codrituzumab + Docetaxel regimen group, both regimens are 4 courses, one every 3 weeks Course of treatment. After the operation, the patient received 3 courses of FEC chemotherapy and continued to use 13 courses of Pertuzumab + codrituzumab or Placebo + codrituzumab until 1 year. The primary endpoint of this study was the total tpCR ([ypT0 / is, ypN0]). When the patient completed the operation, the tpCR results were evaluated by the external review committee (IRC).

PEONY reached the main endpoint of the study. The results showed that the tpCR of the triple target group of tropa was significantly increased to 180% of the single target group of trastap (39.3% vs 21.8%, P = 0.0014), and the safety results were consistent with the previously known Par Safety data of codrituzumab.