Tecentriq Receives Second FDA Approval This Month as First-Line Therapy for Extensive-Stage Small Cell Lung Cancer

Source: Sina Medical News 　2019-03-20                                                         A-A+

Genentech, a Roche company (Genentech）3Month19announced itsPD-L1Monoclonal AntibodyTecentriqThis month from the United StatesFDASecond approval obtained. This approvalTecentriqCombination chemotherapy (carboplatin and etoposide) for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) patients. This approval marks20For years, this refractory lung cancer has seen its first new first-line treatment option.

ThisPD-L1The latest approval of the inhibitor is based on clinicalIIIPhaseIMpower133of the research results, this is aIIIPhase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study in Chemotherapy-Naïve AdultsES-SCLCPatient AssessmentTecentriqEfficacy and Safety of Combination Chemotherapy (Carboplatin and Etoposide) versus Monotherapy (Carboplatin and Etoposide). The study showed that,TecentriqPatients with this disease who receive combination chemotherapy have longer survival than those receiving chemotherapy alone. This is the first study targetingES-SCLCThe patient's first-line treatment is based on immunotherapy.IIIPhase studies have shown that combination therapy significantly improves overall survival (OS=12.3 vs. 10.3/month). In addition to improving overall survival, the combination therapy also improved progression-free survival in the same patient cohort (PFS=5.2 vs.4.3/month).

Furthermore, the safety profile of the combination therapy appears consistent with the known safety profiles of the monotherapies, and no new safety signals have been identified. Patients receivingTecentriq+Among patients receiving combination chemotherapy37% experienced serious adverse reactions, whereas patients receiving chemotherapy alone had35％。Tecentriq+The most common adverse reactions (≥20%) as fatigue or weakness (39%), nausea (38%), alopecia (37%), decreased appetite (27%), constipation (26%) and vomiting (20％）。

Chief Medical Officer and Head of Global Product Development, GenentechSandra Horningstated in a statement, “TecentriqIt is the first tumor immunotherapy approved for first-line treatment of extensive-stage small cell lung cancer. To date, therapeutic options with demonstrated progress in treating this disease have been limited. We are pleased to bring patients a potential new standard of care that has been shown to improve survival rates compared with chemotherapy.”

LUNGevityPresident and Chief Executive Officer of the FoundationAndrea FerrisIt is pointed out that “extensive-stage small cell lung cancer is a highly aggressive form of lung cancer. In the past20No significant treatment progress was observed by mid-year. TodayTecentriq“The approval of the combination therapy is an important step forward in ensuring that patients with various types of lung cancer have access to effective new treatments.”

In fact, this approval isTecentriqThe second approval this month. In less than10days ago,FDAApprovedTecentriqCombined chemotherapy is used forPD-L1Adult patients with positive, metastatic triple-negative breast cancer. In this indication,TecentriqAccelerated approval was granted based on positive progression-free survival data. ItsIIIPhaseIMpassion130Trial data show that, inPD-L1Among patients with triple-negative breast cancer who are positive and have not received prior chemotherapy, compared to using alonenab-paclitaxel，TecentriqCombinednab-paclitaxelSignificantly reduced in patients40%ofPFSRisk.

According to the American Cancer Society,2019It is estimated that more than228,000Americans were diagnosed with lung cancer. Of these, approximately84% are the most common non-small cell lung cancer, with the remaining16%It may be small cell lung cancer. Most (approximately70％）SCLCThe patient was diagnosed withES-SCLC. The five-year survival rate for patients diagnosed with lung cancer at any stage in the United States is estimated to be18%, improving overall survival is a major focus in lung cancer treatment.

TecentriqApproved for use in combinationAvastinPaclitaxel and Carboplatin as First-Line Treatment for Adult Metastatic Non-Squamous Non-Small Cell Lung Cancer(NSCLC)and noneEGFRGene orALKPatients with gene tumor mutations. Additionally,Tecentriqalso byFDAApproved for the treatment of adult metastaticNSCLCPatients who experienced disease progression during or after platinum-based chemotherapy. (Compiled by Sina Medicine)/Bernardo）

Article reference source:

1、Genentech’s Tecentriq Wins Approval for ES-SCLC, Its Second of the Month

2、FDA approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer

*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.