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China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

01:00 EST 14 Feb 2020 | Hoffmann-La Roche Ltd

Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

“Small cell lung cancer is an area of major unmet need in China and one that has seen limited advances until now,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This approval makes Tecentriq the first cancer immunotherapy available in China for the initial treatment of extensive-stage small cell lung cancer less than a year after the US FDA and EMA approvals, marking a swift and important step forward for patients with this aggressive and difficult-to-treat disease.”

Lung cancer is the most common cancer and the leading cause of cancer death in China.1 Overall, SCLC accounts for around 15% of all lung cancer cases and, with two-thirds of patients diagnosed at the ‘extensive’ stage, the prognosis for people with this form of the disease is poor.2 The average five-year survival for people with ES-SCLC is only 2%.3

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 versus 10.3 months; HR=0.70, 95% CI: 0.54–0.91; p=0.0069). The combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=5.2 versus 4.3 months; hazard ratio [HR]=0.77; 95% CI: 0.62–0.96; p=0.017).4 Follow-up analysis suggests that at 18 months the OS rate was 34% for people receiving the Tecentriq-based treatment versus 21% for people receiving chemotherapy alone. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq. The results represent the first clinically meaningful advance in the first-line treatment of ES-SCLC in more than 20 years.

In January 2020, the China NMPA also accepted the supplemental Biologics License Application (sBLA) for Tecentriq in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer, who have not received prior systemic therapy. The submission is based on the results from the Phase III IMbrave150 study, which met both of its co-primary endpoints, demonstrating statistically significant and clinically meaningful improvements in OS and PFS compared with current standard of care, sorafenib.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower133 study
IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC. The study enrolled 403 people who were randomised equally (1:1) to receive:

Original Article: China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

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