Roche's Kadcyla Files for New Indication in China; Two Domestic ADCs Enter Phase III Trials

By Zhang Xiaoyi

According to the CDE website, on May 27, Roche’s marketing application for a new indication of trastuzumab injection was accepted.

In January 2020, trastuzumab emtansine was approved for import, indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after receiving neoadjuvant therapy based on taxanes combined with trastuzumab.

Ado-trastuzumab emtansine (brand name Kadcyla) is an antibody-drug conjugate (ADC) composed of the anti-HER2 targeted therapy trastuzumab linked via a thioether linker to DM1, a chemotherapy agent that inhibits microtubule assembly. It exhibits “biological missile”-like properties, specifically targeting and killing tumor cells. Co-developed by Roche and ImmunoGen, the drug was approved by the FDA in 2013 for the treatment of patients with HER2-positive advanced breast cancer who had previously received trastuzumab and taxane-based chemotherapy but experienced treatment failure.

Since its market launch, Kadcyla’s annual sales have grown year by year (see table below). According to Roche’s H1 2019 financial report, Kadcyla’s sales in the first half of 2019 reached CHF 636 million, ranking 11th among Roche’s products by sales revenue for that period. Based on this performance, Kadcyla’s global sales in 2019 are expected to surpass CHF 1 billion, solidifying its status as a bona fide blockbuster product.

In addition to the indication for breast cancer, multiple indications of trastuzumab emtansine are under investigation, with the most advanced research being in the field of gastric cancer.

(Source: Insight Database, https://db.dxy.cn)

Antibody-Drug Conjugates (ADCs) consist of three components: a monoclonal antibody, a linker, and a cytotoxic small-molecule drug. This class of therapeutics bridges the gap between antibody-based drugs and traditional chemotherapy agents, enhancing drug specificity and improving the therapeutic window. In recent years, numerous companies both in China and abroad have actively pursued development in this field; however, to date, only eight ADC drugs have been approved for marketing worldwide.

Currently, two ADC drugs have been approved for import in China. On May 14, Takeda China announced that Adcetris® (brentuximab vedotin for injection) had officially received approval from the National Medical Products Administration for the treatment of adult patients with CD30-positive relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) and classical Hodgkin lymphoma (cHL).

According to the Insight clinical database, there are currently 51 ADC-related clinical trials underway, including 13 Phase III trials. The details are as follows.

Source: Insight Database

Original Title: Roche’s “Trastuzumab Emtansine” New Indication Submitted for Marketing Approval; Two Domestically Produced ADCs Enter Phase III