On June 3rd, at 5:00 PM local time (6:00 AM Beijing time on June 4th), during the American Society of Clinical Oncology (ASCO) annual meeting, Professor Liu Qiang from Sun Yat-sen Memorial Hospital of Sun Yat-sen University presented the TORCHLIGHT study led by Professor Jiang Zefei from the Fifth Medical Center of the Chinese People's Liberation Army General Hospital. The study demonstrated positive results of the combination therapy of trastuzumab with albumin-bound paclitaxel in the treatment of advanced triple-negative breast cancer (TNBC), offering a "Chinese solution" to global immunotherapy for TNBC. "Tumor Outlook" had a special interview with Professor Jiang Zefei, the principal investigator (PI) of the TORCHLIGHT study, to provide readers with the latest research progress and clinical significance.Tumor Outlook: Please provide some background on the TORCHLIGHT study in the context of the current status of breast cancer immunotherapy both domestically and internationally. How did you overcome challenges during the three-year period of the pandemic to complete this multicenter phase III trial?
Professor Jiang Zefei: Thank you for the interview. I am very pleased to announce the results of the TORCHLIGHT study during the ASCO annual meeting. We are now in the era of precision classification and treatment of breast cancer, but triple-negative breast cancer remains primarily treated with chemotherapy. Today, immunotherapy for triple-negative breast cancer has entered clinical research, and studies like TORCHLIGHT have shown promising results, improving long-term survival and prognosis for patients. As one of the investigators of the TORCHLIGHT study, we are very pleased with these results. I would like to express my gratitude to all the patients, their families, research doctors, research nurses, and the collaborative teams for their contributions to the study. The TORCHLIGHT study lasted a long time and faced challenges during the pandemic, but we overcame many unimaginable difficulties to ensure that patients could safely receive effective treatment and achieve desirable results. Therefore, I hope that the results of the TORCHLIGHT study will be adopted by regulatory authorities soon, and trastuzumab will be approved for clinical use, benefiting more patients with a better treatment strategy.
Tumor Outlook: The TORCHLIGHT study reported at ASCO has yielded positive results. How do you evaluate the efficacy and safety of the “Chinese solution,” the combination of trastuzumab and albumin-bound paclitaxel?
Professor Jiang Zefei: Albumin-bound paclitaxel has become one of the standard choices for triple-negative breast cancer. Due to its high efficiency and low toxicity, it is more suitable for combination with immunotherapy. Previous international studies have also confirmed the benefits of immunotherapy combined with albumin-bound paclitaxel, while combining with conventional paclitaxel has not been successful. For these reasons, we chose albumin-bound paclitaxel combined with trastuzumab at the outset of the TORCHLIGHT study design, and we achieved desirable efficacy.
Figure 1: TORCHLIGHT Study Design
For patients who achieved excellent efficacy with the combination of albumin-bound paclitaxel and trastuzumab, we included a pathway in the study design for those who could not tolerate chemotherapy to discontinue chemotherapy and continue with immunotherapy. This provides patients with a sustainable and safe management strategy, allowing them to gain better long-term survival benefits. We would like to express our gratitude once again to the patients for their cooperation and to the research team for their meticulous management. It is their efforts that have ensured the efficacy and safety of the patients participating in the study. We also sincerely thank all the research teams for their careful and special care for the patients throughout the entire study period, especially during the three years of the pandemic, ensuring that patients from all regions could receive safe and effective treatment.
Figure 2: Primary Study Endpoint: PFS in PD-L1+ Population Evaluated by BICR
Figure 3: Primary Study Endpoint: PFS in ITT Population Evaluated by BICR
Tumor Outlook: Trastuzumab, as the first domestically produced PD-1 monoclonal antibody approved for marketing in China, has obtained six indications in the five major tumor types. How do you think the publication of the TORCHLIGHT study results will impact the clinical treatment landscape for triple-negative breast cancer patients?
Professor Jiang Zefei: The TORCHLIGHT study was first presented at the ASCO conference and will subsequently be released at our BOA and CSCO meetings, followed by full publication soon. I believe the TORCHLIGHT study will definitely influence guidelines and change clinical practice. The guidance provided in the “CSCO BC Guidelines” is based on the best current evidence-based medicine and consensus opinions from experts, taking into account better product accessibility. Trastuzumab, as a product developed independently in China, and the TORCHLIGHT study, as a study independently conducted in China, will likely be prioritized for acceptance in the Chinese guidelines, reshaping the diagnostic and treatment landscape. We will promptly update the printed and digital versions of the “CSCO BC Guidelines” based on the latest research advancements, allowing more colleagues, patients, and the general public to understand the forefront of developments and guideline updates, thus enabling advanced triple-negative breast cancer patients to receive life extension and improved quality of life through trastuzumab treatment.
