China's First Anti-HER2 Antibody-Drug Conjugate Trastuzumab Emtansine Launched, Completing Full-Course HER2-Positive Breast Cancer Treatment Coverage
Apr 20, 2020 15:32
CST Updated
Apr 18, 10:14
Roche
Oncology Drug Research, Development, and Manufacturing
Following pertuzumab, Roche’s another blockbuster innovative targeted therapy for HER2-positive breast cancer, trastuzumab emtansine, has recently been officially launched in China. As the first antibody-drug conjugate (ADC) milestone targeted anticancer drug to enter the Chinese market, trastuzumab emtansine, with its novel mechanism of action, will reduce the risk of recurrence or death by 50% in patients with HER2-positive early-stage breast cancer who have residual disease after neoadjuvant therapy. The launch of trastuzumab emtansine provides a new treatment option for patients with HER2-positive early-stage breast cancer at high risk of recurrence, and also marks that all three “sister” drugs of Roche’s anti-HER2-positive breast cancer portfolio—trastuzumab, pertuzumab, and trastuzumab emtansine—are now available in China, achieving comprehensive coverage across the entire treatment journey for Chinese patients with HER2-positive breast cancer.
Striving for Excellence: Landmark Evidence Opens New Avenues for Optimized Patient Treatment
It is well known that HER2-positive breast cancer generally carries a poor prognosis; however, the use of trastuzumab has improved survival outcomes for patients with HER2-positive breast cancer to levels comparable to those with HER2-negative breast cancer. Therefore, anti-HER2 therapy is crucial for the management of HER2-positive breast cancer.
In patients with HER2-positive early breast cancer receiving adjuvant trastuzumab therapy, a subset still experiences recurrence and metastasis after 10 years. Furthermore, approximately 40–60% of patients treated with neoadjuvant dual-targeted therapy using trastuzumab plus pertuzumab fail to achieve pathological complete response (pCR). These patients who do not achieve pCR following neoadjuvant therapy have a higher risk of recurrence within five years compared to those who do achieve pCR, with the risk in some cases approaching nearly 80%. The KATHERINE study has brought hope to this patient population.
The KATHERINE study represents a major breakthrough in the field of anti-HER2 therapy for breast cancer. Professor Lin Ying, Chief Physician and Deputy Director of the Department of Thyroid and Breast Surgery at the First Affiliated Hospital of Sun Yat-sen University, stated, “This study proposes a novel treatment strategy for patients with HER2-positive early-stage breast cancer who have residual disease after neoadjuvant therapy. For the first time, the KATHERINE study focused on patients who did not achieve pathological complete response (pCR) and confirmed the significant value of trastuzumab emtansine in the treatment of early-stage HER2-positive breast cancer. It provides new milestone evidence for optimizing treatment in HER2-positive breast cancer patients and opens up new avenues for therapeutic approaches.”
Stunning Debut: A Novel Mechanism Brings New Hope to Patients
The remarkable efficacy of trastuzumab emtansine in treatment is closely attributed to its innovative mechanism of action. The field of breast cancer continues to advance steadily. Trastuzumab emtansine is the first antibody-drug conjugate (ADC) approved globally as monotherapy for solid tumors, and the first HER2-targeted ADC product in China. For patients with HER2-positive breast cancer who have residual disease after neoadjuvant therapy, treatment with trastuzumab emtansine can further reduce the risk of disease recurrence and death¹, thereby addressing an unmet medical need in China for HER2-positive breast cancer patients who do not achieve pathological complete response (non-pCR) following neoadjuvant therapy. Jiajia Qiu, Deputy Director of the Nursing Department at Fudan University Shanghai Cancer Center, stated, “The use of trastuzumab emtansine will significantly enhance patients’ confidence in treatment and recovery. The clinical application of this innovative product will bring hope for cure to more patients and their families, while also filling healthcare professionals with greater optimism regarding the treatment and rehabilitation of breast cancer.”
Trastuzumab deruxtecan has become a turning point in the treatment of HER2-positive breast cancer. Through ingenious design, this stable antibody-drug conjugate (ADC) links trastuzumab, a classic anti-HER2 targeted therapy, with deruxtecan, a chemotherapy agent that inhibits microtubule assembly, via a thioether linker. Possessing the characteristic ability to target and kill tumor cells, it is also known as a "biological missile." It can directly deliver potent chemotherapy drugs to HER2-positive cancer cells, fully leveraging the effects of targeted therapy while exerting cytotoxic chemotherapy effects, simultaneously limiting damage to healthy tissues. This brings new hope for patients who do not achieve pathological complete response (non-pCR).
Continuous Innovation, Comprehensive Management for Patient Benefit Throughout the Care Journey
With the market launch of trastuzumab emtansine, Roche’s three major breast cancer drugs—Herceptin® (trastuzumab), Perjeta® (pertuzumab), and Kadcyla® (trastuzumab emtansine)—have established a comprehensive anti-HER2 treatment system covering the entire continuum of care, from initial neoadjuvant therapy and postoperative adjuvant therapy to first-line treatment for advanced disease. Furthermore, beyond HER2-positive breast cancer, Roche has also made progress in the treatment of triple-negative breast cancer (TNBC), one of the most aggressive subtypes. Atezolizumab, its anti-PD-L1 tumor immunotherapy drug, has received FDA approval as the world’s first tumor immunotherapy for the treatment of triple-negative breast cancer.
Zhou Hong, President of Roche China, stated, “Since the launch of Herceptin® in 1998, Roche has achieved significant breakthroughs and progress in the diagnosis and treatment of breast cancer. Moving forward, we will continue to uphold our philosophy of ‘putting patients first’ by accelerating the introduction of more innovative products into China. Our goal is to provide comprehensive coverage for Chinese breast cancer patients across all disease stages—from early to late—thereby maximizing patient benefits throughout their care journey and addressing the unmet needs of the broad breast cancer community in China.”
It is reported that trastuzumab emtansine was approved by the National Medical Products Administration on January 20 this year for use in patients with HER2-positive early-stage breast cancer who have residual invasive disease after neoadjuvant therapy based on taxanes combined with trastuzumab. Just three months after approval, Kadcyla® was introduced into clinical practice in China. This tightly coordinated and accelerated process aims to ensure that patients can access innovative medicines as soon as possible.
Striving for Excellence: Landmark Evidence Opens New Avenues for Optimized Patient Treatment
It is well known that HER2-positive breast cancer generally carries a poor prognosis; however, the use of trastuzumab has improved survival outcomes for patients with HER2-positive breast cancer to levels comparable to those with HER2-negative breast cancer. Therefore, anti-HER2 therapy is crucial for the management of HER2-positive breast cancer.
In patients with HER2-positive early breast cancer receiving adjuvant trastuzumab therapy, a subset still experiences recurrence and metastasis after 10 years. Furthermore, approximately 40–60% of patients treated with neoadjuvant dual-targeted therapy using trastuzumab plus pertuzumab fail to achieve pathological complete response (pCR). These patients who do not achieve pCR following neoadjuvant therapy have a higher risk of recurrence within five years compared to those who do achieve pCR, with the risk in some cases approaching nearly 80%. The KATHERINE study has brought hope to this patient population.
The KATHERINE study represents a major breakthrough in the field of anti-HER2 therapy for breast cancer. Professor Lin Ying, Chief Physician and Deputy Director of the Department of Thyroid and Breast Surgery at the First Affiliated Hospital of Sun Yat-sen University, stated, “This study proposes a novel treatment strategy for patients with HER2-positive early-stage breast cancer who have residual disease after neoadjuvant therapy. For the first time, the KATHERINE study focused on patients who did not achieve pathological complete response (pCR) and confirmed the significant value of trastuzumab emtansine in the treatment of early-stage HER2-positive breast cancer. It provides new milestone evidence for optimizing treatment in HER2-positive breast cancer patients and opens up new avenues for therapeutic approaches.”
Stunning Debut: A Novel Mechanism Brings New Hope to Patients
The remarkable efficacy of trastuzumab emtansine in treatment is closely attributed to its innovative mechanism of action. The field of breast cancer continues to advance steadily. Trastuzumab emtansine is the first antibody-drug conjugate (ADC) approved globally as monotherapy for solid tumors, and the first HER2-targeted ADC product in China. For patients with HER2-positive breast cancer who have residual disease after neoadjuvant therapy, treatment with trastuzumab emtansine can further reduce the risk of disease recurrence and death¹, thereby addressing an unmet medical need in China for HER2-positive breast cancer patients who do not achieve pathological complete response (non-pCR) following neoadjuvant therapy. Jiajia Qiu, Deputy Director of the Nursing Department at Fudan University Shanghai Cancer Center, stated, “The use of trastuzumab emtansine will significantly enhance patients’ confidence in treatment and recovery. The clinical application of this innovative product will bring hope for cure to more patients and their families, while also filling healthcare professionals with greater optimism regarding the treatment and rehabilitation of breast cancer.”
Trastuzumab deruxtecan has become a turning point in the treatment of HER2-positive breast cancer. Through ingenious design, this stable antibody-drug conjugate (ADC) links trastuzumab, a classic anti-HER2 targeted therapy, with deruxtecan, a chemotherapy agent that inhibits microtubule assembly, via a thioether linker. Possessing the characteristic ability to target and kill tumor cells, it is also known as a "biological missile." It can directly deliver potent chemotherapy drugs to HER2-positive cancer cells, fully leveraging the effects of targeted therapy while exerting cytotoxic chemotherapy effects, simultaneously limiting damage to healthy tissues. This brings new hope for patients who do not achieve pathological complete response (non-pCR).
Continuous Innovation, Comprehensive Management for Patient Benefit Throughout the Care Journey
With the market launch of trastuzumab emtansine, Roche’s three major breast cancer drugs—Herceptin® (trastuzumab), Perjeta® (pertuzumab), and Kadcyla® (trastuzumab emtansine)—have established a comprehensive anti-HER2 treatment system covering the entire continuum of care, from initial neoadjuvant therapy and postoperative adjuvant therapy to first-line treatment for advanced disease. Furthermore, beyond HER2-positive breast cancer, Roche has also made progress in the treatment of triple-negative breast cancer (TNBC), one of the most aggressive subtypes. Atezolizumab, its anti-PD-L1 tumor immunotherapy drug, has received FDA approval as the world’s first tumor immunotherapy for the treatment of triple-negative breast cancer.
Zhou Hong, President of Roche China, stated, “Since the launch of Herceptin® in 1998, Roche has achieved significant breakthroughs and progress in the diagnosis and treatment of breast cancer. Moving forward, we will continue to uphold our philosophy of ‘putting patients first’ by accelerating the introduction of more innovative products into China. Our goal is to provide comprehensive coverage for Chinese breast cancer patients across all disease stages—from early to late—thereby maximizing patient benefits throughout their care journey and addressing the unmet needs of the broad breast cancer community in China.”
It is reported that trastuzumab emtansine was approved by the National Medical Products Administration on January 20 this year for use in patients with HER2-positive early-stage breast cancer who have residual invasive disease after neoadjuvant therapy based on taxanes combined with trastuzumab. Just three months after approval, Kadcyla® was introduced into clinical practice in China. This tightly coordinated and accelerated process aims to ensure that patients can access innovative medicines as soon as possible.