Lung Cancer Immunotherapy Gains FDA Approval
Tecentriq is a monoclonal antibody designed to bind with a protein which may enable the activation of T cells
The US Food and Drug Administration (FDA) recently approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
Announced by Roche in a press release published on December 4, 2019, this approval is based on results from the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer when compared to chemotherapy alone 18.6 versus 13.9 months.
The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival) compared with chemotherapy alone, 7.2 versus 6.5 months.
In lung cancer, Tecentriq is also approved in the USA in combination with Avastin®, paclitaxel and carboplatin, for the initial treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq.
Tecentriq is also approved in the USA in combination with carboplatin and etoposide for the initial treatment of adults with extensive-stage small-cell lung cancer.
Roche has an extensive development program for Tecentriq, including nine Phase III studies underway across different types of lung cancer, and multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.
These studies include evaluating Tecentriq both alone and in combination with other medicines.
IMpower130 is a Phase III, multicentre, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination with nab-paclitaxel and carboplatin versus chemotherapy (nab-paclitaxel and carboplatin) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC.
The study enrolled 724 people, of whom 681 were in the ITT-WT population and were randomized (2:1) to receive:
- Tecentriq plus nab-paclitaxel and carboplatin (Arm A), or
- Nab-paclitaxel and carboplatin (Arm B, control arm)
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first.
People in Arm A received Tecentriq during the maintenance treatment phase until a loss of clinical benefit was observed.
During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People in Arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted.
People who consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until further disease progression.
The co-primary endpoints were:
- PFS, as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations (the ITT-WT population)
- OS in the ITT-WT population
“We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
Lung cancer is the leading cause of cancer death globally.
Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.
Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer.
NSCLC is the most prevalent type, accounting for around 85% of all cases. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterized by flat cells covering the airway surface when viewed under a microscope.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells.
Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.
Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.
Lung Cancer Immunotherapy news published by Vax Before Cancer