Roche's Immunotherapy Drug Tecentriq® Launched in China, Ending 30-Year Therapeutic Drought in Extensive-Stage Small Cell Lung Cancer
Apr 29, 2020 18:57
CST Updated
Apr 30, 11:51
Roche
Oncology Drug Research, Development, and Manufacturing
On April 29, Roche’s innovative cancer immunotherapy drug Tecentriq® (generic name: atezolizumab), in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), was officially launched in China. This marks the first indication for which Tecentriq® has been approved and marketed in China. On February 13 this year, the National Medical Products Administration of China formally approved Tecentriq® in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer, signifying Roche’s official entry into the Chinese market for this indication.TumorIn the field of immunotherapy, Chinese patients with small cell lung cancer now have treatment options available, ending a 30-year "drug drought."
· Tecentriq® (generic name: atezolizumab) in combination with chemotherapy is the first globally, and currently the only one approved in China, for the first-line treatment of extensive-stage small cell lung cancer.TumorImmunotherapy.
· Tecentriq® (generic name: atezolizumab) in combination with chemotherapy is the first globally, and currently the only one approved in China, for the first-line treatment of extensive-stage small cell lung cancer.TumorImmunotherapy.
· Tecentriq® is also the first innovative drug proven to deliver significant benefits to patients with small cell lung cancer in over 30 years.
Urgent Clinical Needs: Patient Survival Outcomes Require Immediate Improvement
Malignant tumors have become one of the major public health issues seriously threatening the health of the Chinese population. According to the 2017 report "Current Status and Trends of Cancer in China," lung cancer has ranked first among malignant tumors in China for 16 consecutive years.TumorRanking first in incidence, the number of deaths from lung cancer in China was approximately 631,000 in 2015, with a mortality rate of 45.87 per 100,000 population. In recent years, the incidence of lung cancer has continued to rise annually and shows a trend toward affecting younger populations.
Based on histopathological classification, lung cancer can be divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). SCLC accounts for approximately 15% of all lung cancer cases and is a highly aggressive malignancy characterized by rapid proliferation.Tumor. The prognosis for patients with small cell lung cancer is extremely poor; two-thirds of patients present with extensive-stage disease at initial diagnosis, indicating metastasis to distant organs or lymph nodes at the time of detection, and the 5-year average survival rate after diagnosis is only 2%.
Vice Chairman of the Chinese Society of Clinical Oncology (CSCO), Chairman of the CSCO Small Cell Lung Cancer Professional Committee, Jilin ProvinceTumorProfessor Cheng Ying from the hospital introduced, “Small cell lung cancer (SCLC) is the most aggressive subtype of lung cancer, progressing rapidly. When patients experience symptoms such as shortness of breath and persistent cough, they often already have metastasis by the time they seek medical attention. Etoposide combined with platinum-based chemotherapy has been the standard first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) for over 30 years. Although most patients achieve remission after initial treatment, recurrence and drug resistance occur quickly, and there is a lack of effective treatments post-recurrence. Therefore, the five-year survival rate for ES-SCLC remains very low.”
Innovative Immunotherapy “Breaks the Deadlock,” Bringing Greater Benefits to Patients
The approval and market launch of Tecentriq® (atezolizumab) in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer was primarily based on a global, multicenter, Phase IIIClinical TrialIMpower133 Trial Results. This trial enrolled 403 patients with extensive-stage small cell lung cancer (ES-SCLC), who were randomized into two groups to compare the efficacy and safety of Tecentriq® (atezolizumab) in combination with chemotherapy versus chemotherapy alone in the treatment of small cell lung cancer.
The study demonstrated that the Tecentriq® (atezolizumab) plus chemotherapy regimen significantly reduced the risk of disease progression and death (PFS: 5.2 vs. 4.3 months; HR=0.77, 95% CI: 0.62-0.96; p=0.017). The study also indicated that Tecentriq® (atezolizumab) combined with chemotherapy provides durable benefits for patients with small cell lung cancer (SCLC). During a follow-up period of 13.9 months, the proportion of patients in the experimental group who maintained sustained disease response was three times that of the chemotherapy group (15% vs. 5%). With longer-term follow-up, one-third of patients receiving Tecentriq® (atezolizumab) plus chemotherapy survived beyond 18 months, representing a significant increase compared to 21% in the chemotherapy group. Regarding safety, the profile of the Tecentriq® plus chemotherapy group was consistent with the previously established safety profile of Tecentriq®.
Professor Cheng Ying stated: “The IMpower133 study is the first Phase III trial to demonstrate positive results for immunotherapy as first-line treatment in extensive-stage small cell lung cancer (ES-SCLC), with China contributing 100 patients to this study. The results showed that the median overall survival in the Tecentriq® plus chemotherapy group reached 12.3 months. Compared with standard chemotherapy, Tecentriq® combined with chemotherapy significantly prolonged overall survival and reduced the risk of death in patients with ES-SCLC. The IMpower133 study is the first Phase III trial in 30 years to show a median survival improvement in the systemic treatment of ES-SCLC, marking a milestone in first-line therapy for this disease and establishing a new standard of care. The launch of Tecentriq® signifies that China has officially entered a new era of immunotherapy for small cell lung cancer.”
Tecentriq® is an innovative monoclonal antibody independently developed by Roche for cancer immunotherapy. Unlike cancer immunotherapies that specifically target PD-1, Tecentriq® binds to the PD-L1 protein on the surface of tumor cells and tumor-infiltrating immune cells. This not only blocks the interaction between PD-L1 and the PD-1 receptor but also prevents PD-L1 from binding to the B7.1 receptor, thereby helping the human immune system recognize tumor cells and further activating T cells to attack them.TumorCell.
The launch of Tecentriq® in China marks Roche’s comprehensive coverage in the field of lung cancer treatment in China, providing a full range of personalized treatment options for lung cancer patients across the country:
· Tarceva® (generic name: erlotinib hydrochloride), a drug for the treatment of non-small cell lung cancer with EGFR gene mutations
· Anti-angiogenic drug Avastin® (generic name: bevacizumab)
· Alectinib (generic name: alectinib), marketed as Alecensa®, for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer
· Treatment of extensive-stage small cell lung cancerTumorImmuno-oncology innovative drug Tecentriq® (generic name: atezolizumab)
Furthermore, Roche is conducting Phase III clinical trials on rare lung cancer targets such as NTRK and ROS1, further advancing personalized treatment for lung cancer.
Urgent Clinical Needs: Patient Survival Outcomes Require Immediate Improvement
Malignant tumors have become one of the major public health issues seriously threatening the health of the Chinese population. According to the 2017 report "Current Status and Trends of Cancer in China," lung cancer has ranked first among malignant tumors in China for 16 consecutive years.TumorRanking first in incidence, the number of deaths from lung cancer in China was approximately 631,000 in 2015, with a mortality rate of 45.87 per 100,000 population. In recent years, the incidence of lung cancer has continued to rise annually and shows a trend toward affecting younger populations.
Based on histopathological classification, lung cancer can be divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). SCLC accounts for approximately 15% of all lung cancer cases and is a highly aggressive malignancy characterized by rapid proliferation.Tumor. The prognosis for patients with small cell lung cancer is extremely poor; two-thirds of patients present with extensive-stage disease at initial diagnosis, indicating metastasis to distant organs or lymph nodes at the time of detection, and the 5-year average survival rate after diagnosis is only 2%.
Vice Chairman of the Chinese Society of Clinical Oncology (CSCO), Chairman of the CSCO Small Cell Lung Cancer Professional Committee, Jilin ProvinceTumorProfessor Cheng Ying from the hospital introduced, “Small cell lung cancer (SCLC) is the most aggressive subtype of lung cancer, progressing rapidly. When patients experience symptoms such as shortness of breath and persistent cough, they often already have metastasis by the time they seek medical attention. Etoposide combined with platinum-based chemotherapy has been the standard first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) for over 30 years. Although most patients achieve remission after initial treatment, recurrence and drug resistance occur quickly, and there is a lack of effective treatments post-recurrence. Therefore, the five-year survival rate for ES-SCLC remains very low.”
Innovative Immunotherapy “Breaks the Deadlock,” Bringing Greater Benefits to Patients
The approval and market launch of Tecentriq® (atezolizumab) in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer was primarily based on a global, multicenter, Phase IIIClinical TrialIMpower133 Trial Results. This trial enrolled 403 patients with extensive-stage small cell lung cancer (ES-SCLC), who were randomized into two groups to compare the efficacy and safety of Tecentriq® (atezolizumab) in combination with chemotherapy versus chemotherapy alone in the treatment of small cell lung cancer.
The study demonstrated that the Tecentriq® (atezolizumab) plus chemotherapy regimen significantly reduced the risk of disease progression and death (PFS: 5.2 vs. 4.3 months; HR=0.77, 95% CI: 0.62-0.96; p=0.017). The study also indicated that Tecentriq® (atezolizumab) combined with chemotherapy provides durable benefits for patients with small cell lung cancer (SCLC). During a follow-up period of 13.9 months, the proportion of patients in the experimental group who maintained sustained disease response was three times that of the chemotherapy group (15% vs. 5%). With longer-term follow-up, one-third of patients receiving Tecentriq® (atezolizumab) plus chemotherapy survived beyond 18 months, representing a significant increase compared to 21% in the chemotherapy group. Regarding safety, the profile of the Tecentriq® plus chemotherapy group was consistent with the previously established safety profile of Tecentriq®.
Professor Cheng Ying stated: “The IMpower133 study is the first Phase III trial to demonstrate positive results for immunotherapy as first-line treatment in extensive-stage small cell lung cancer (ES-SCLC), with China contributing 100 patients to this study. The results showed that the median overall survival in the Tecentriq® plus chemotherapy group reached 12.3 months. Compared with standard chemotherapy, Tecentriq® combined with chemotherapy significantly prolonged overall survival and reduced the risk of death in patients with ES-SCLC. The IMpower133 study is the first Phase III trial in 30 years to show a median survival improvement in the systemic treatment of ES-SCLC, marking a milestone in first-line therapy for this disease and establishing a new standard of care. The launch of Tecentriq® signifies that China has officially entered a new era of immunotherapy for small cell lung cancer.”
Tecentriq® is an innovative monoclonal antibody independently developed by Roche for cancer immunotherapy. Unlike cancer immunotherapies that specifically target PD-1, Tecentriq® binds to the PD-L1 protein on the surface of tumor cells and tumor-infiltrating immune cells. This not only blocks the interaction between PD-L1 and the PD-1 receptor but also prevents PD-L1 from binding to the B7.1 receptor, thereby helping the human immune system recognize tumor cells and further activating T cells to attack them.TumorCell.
The launch of Tecentriq® in China marks Roche’s comprehensive coverage in the field of lung cancer treatment in China, providing a full range of personalized treatment options for lung cancer patients across the country:
· Tarceva® (generic name: erlotinib hydrochloride), a drug for the treatment of non-small cell lung cancer with EGFR gene mutations
· Anti-angiogenic drug Avastin® (generic name: bevacizumab)
· Alectinib (generic name: alectinib), marketed as Alecensa®, for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer
· Treatment of extensive-stage small cell lung cancerTumorImmuno-oncology innovative drug Tecentriq® (generic name: atezolizumab)
Furthermore, Roche is conducting Phase III clinical trials on rare lung cancer targets such as NTRK and ROS1, further advancing personalized treatment for lung cancer.