Chugai Subsidiary of Roche Receives Japanese Approval for Kadcyla as Adjuvant Therapy in HER2-Positive Early Breast Cancer

August 23, 2020 /BioonBIOON/ -- Chugai Pharmaceutical, a Japanese pharmaceutical company controlled by Roche, recently announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved the HER2-targeted drug Kadcyla (trastuzumab emtansine) as an adjuvant therapy for HER2-positive early-stageBreast CancerAn additional indication for patients with (eBC), specifically: adjuvant (postoperative) treatment for patients with HER2-positive early breast cancer (eBC) who have residual invasive disease after receiving neoadjuvant (preoperative) therapy. In the United States and the European Union, Kadcyla was approved for this indication in May 2019 and December 2019, respectively.

Previously, the approved indication for Kadcyla was: treatment of patients with unresectable or recurrent HER2-positive breast cancer. This latest approval,Kadcyla will provide a new postoperative treatment option to improve prognosis for patients with HER2-positive early breast cancer who do not achieve pathological complete response (pCR) after neoadjuvant (preoperative) therapy.

This approval is based on data from the open-label, randomized, global Phase III KATHERINE study. The study evaluated the efficacy and safety of Kadcyla as adjuvant (postoperative) therapy in 1,486 patients with HER2-positive early breast cancer who did not achieve pathological complete response (pCR) following neoadjuvant therapy (including Herceptin).

The results showed that, in terms of the primary endpoint of invasive disease-free survival (iDFS),Compared with adjuvant Herceptin therapy, adjuvant Kadcyla therapy demonstrated superiority, significantly reducing the risk of invasive breast cancer recurrence or all-cause mortality by 50% (HR=0.50, 95% CI: 0.39–0.64, p<0.0001).

After 3 years of treatment,In the Kadcyla treatment group, 83.3% of patients had no breast cancer recurrence, compared with 77.0% in the Herceptin treatment group, representing an absolute improvement of 11.3%.In this study, the safety profile of Kadcyla was consistent with that observed in previously approved treatments for HER2-positive metastatic breast cancer, and Kadcyla also demonstrated good tolerability as adjuvant therapy for HER2-positive early-stage breast cancer.

Dr. Osamu Okuda, President and Chief Operating Officer of Chugai Pharmaceutical, stated, “In the treatment of HER2-positive early breast cancer, failure to achieve a pathological complete response (pCR) with neoadjuvant therapy is associated with a poorer prognosis. In the KATHERINE study, Kadcyla reduced the risk of invasive breast cancer recurrence or death by 50% compared with Herceptin. We are very pleased that this approval will address the unmet medical needs in the patient population seeking a cure and help drive therapeutic advancements. AsTumor"As a leading company in the field, Chugai Pharmaceutical will strive to promote the appropriate use of this treatment method to benefit patients."

The treatment goal for early breast cancer (eBC) is to provide patients with the best chance of cure, which, as part of a comprehensive treatment approach, may involve therapies administered before and after surgery. Although we are getting closer to achieving this goal at every step, many patients still experience disease recurrence in the long term. Neoadjuvant therapy administered prior to surgery aims to shrinkTumorand help improve surgical outcomes. The purpose of administering adjuvant therapy after surgery is to eliminate any residual cancer cells in the body, thereby helping to reduce the risk of cancer recurrence.

Kadcyla is one of the three innovative drugs developed by Roche targeting the HER2 signaling pathway, with the other two being Herceptin and Perjeta. The launch of these three drugs has transformed the clinical treatment paradigm for HER2-positive breast cancer. HER2-positive breast cancer is a particularly aggressive form of breast cancer, affecting approximately 15-20% of breast cancer patients. For early-stage breast cancer (eBC), the goal of neoadjuvant (preoperative) therapy is to reduceTumorIts size facilitates easier surgical removal, and the purpose of adjuvant (postoperative) therapy is to eliminate any residual cancer cells to reduce the risk of cancer recurrence.

Kadcyla is a HER2-targeted therapy that was approved for marketing in 2013. To date, it has been approved in more than 100 countries worldwide. It is the first and only antibody-drug conjugate (ADC) approved as a single agent for the treatment of patients with HER2-positive metastatic breast cancer who have previously received trastuzumab (Herceptin) and taxane chemotherapy, either separately or in combination. The drug consists of trastuzumab (the active pharmaceutical ingredient of Herceptin) linked to ImmunoGen’s cytotoxic agent DM1 via a stable linker, thereby delivering DM1 to HER2-positive breast cancer cells. Kadcyla possesses two anticancer properties: the HER2-inhibitory effect of trastuzumab and the cytotoxicity of DM1. (Bioon.com)

Original Source: Chugai Obtainsapproval for Additional Indication of Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer