FDA OKs Roche’s First-Line Treatment for Some Lung Cancers
The FDA approval was based on Roche’s study that found atezolizumab boosted overall survival rate in patients with high PD-L1 expression compared with chemotherapy.
Source: FDA Official
By - FDA recently approved Roche’s first-line treatment, Tecentriq (atezolizumab), for adult patients with metastatic non-small cell lung cancer.
Atezolizumab is the fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the US.
The approval was based on results from Roche’s clinical trial, IMpower110. This was a multicenter, international, open-label trial for patients with stage IV non-small cell lung cancer whose tumors express PD-L1 and who had received no prior chemotherapy for metastatic disease.
A randomized group of patients received atezolizumab 1200mg every three weeks until disease progression or unacceptable toxicity or platinum-based chemotherapy, FDA said.
The main efficacy outcome measure was overall survival.
Researchers found that atezolizumab improved overall patient survival by 7.1 months compared with chemotherapy.
Median survival was 20.2 months for patients for atezolizumab compared with 13.1 months for chemotherapy. There was no statistically significant difference in survival for the other two PD-L1 subgroups at the interim or final analyses.
Additionally, median progression-free survival per investigator was slightly more than eight months for atezolizumab and five months for the platinum-based chemotherapy.
Overall response rate (ORR) per investigator was 38 percent and 29 percent, respectively. Drug safety appeared to be consistent with its known safety profile, and no new safety signals were identified.
Along with atezolizumab, FDA approved VENTANA PD-L1 Assay as a companion diagnostic device for specifically choosing patients with NSCLC for treatment with atezolizumab.
“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche said in a press release.
“Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”
Just 13 percent of individuals reported grade 3–4 treatment-related adverse events when taking atezolizumab compared with 44.1 percent of people receiving chemotherapy.
The most common adverse reaction for patients receiving atezolizumab was fatigue or asthenia. This occurred in fewer than 20 percent of individuals.
The overall recommended atezolizumab dose for treatment of non-small cell lung cancer is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks, administered intravenously over 60 minutes, FDA stated.
Additionally, Roche stated that they have various ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating atezolizumab both alone and in combination with other medicines.
Non-small cell lung cancer accounts for between 80 percent and 85 percent of all lung cancers and is therefore a “lucrative yet competitive space” for pharmaceutical companies, Reuters recently reported in The New York Times.
Keytruda from Merck & Co Inc currently dominates the space, but a flurry of new FDA approvals is bringing new market entrants. In addition to the approval of Tecentriq, the FDA also approved Bristol-Myers Squibb Co's Opdivo and Yervoy combination for use in previously untreated patients with non-small cell lung cancer, Reuters stated.
