Promising new lung cancer drug MPDL3280A backed by FDA

Posted on 2 Jun 2015 by Tim Brown

A new type of treatment, which could double the chances of survival for some patients suffering from the most common type of lung cancer, has been given Breakthrough Therapy Designation by the FDA.

Drug company Roche has been carrying out tests on an immunotherapy treatment, with early results suggesting it could be a better option than chemotherapy for those with non-small cell lung cancer.

The research, which is to be presented at the annual meeting of the American Society of Clinical Oncology, has been welcomed by cancer charities. Jesme Fox, medical director at Roy Castle Lung Cancer Foundation, said: “There is much optimism that immunotherapy will provide a new treatment paradigm for patients with advanced non-small cell lung cancer.”

About 85% of sufferers have non-small cell lung cancer and could potentially be helped by the new treatment, which is known as MPDL3280A. The drug, which had been awarded breakthrough therapy designation by the US Food and Drug Administration (FDA), works by interfering with the PD-L1 protein on tumour cells. By doing this, it may help T cells in the blood, restoring their ability to detect and attack tumour cells.

Genentech, a member of the Roche Group, has revealed that it has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A (anti-PDL1).

The designation was granted for the treatment of people with PD-L1 (Programmed Death-Ligand 1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and an appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor).

“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer,” said Sandra Horning, MD, chief medical officer and head of Global Product Development.

“We are committed to personalised healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines.”

This Breakthrough Therapy Designation is based on early results of MPDL3280A in people whose NSCLC was characterized as PD-L1 positive by an investigational test being developed by Roche. All studies of MPDL3280A are prospectively evaluating PD-L1 expression. Some studies will evaluate the medicine regardless of a tumor’s PD-L1 status; other studies are evaluating the medicine only in people whose tumors are characterized as PD-L1 positive.

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. The FDA granted the first Breakthrough Therapy Designation for MPDL3280A in metastatic bladder cancer in 2014. Ongoing pivotal studies of MPDL3280A include lung and bladder cancer, and we plan to initiate Phase III studies in additional tumor types this year.

About MPDL3280A (anti-PDL1)

MPDL3280A (also known as anti-PDL1 and RG7446) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.

About Lung Cancer

According to the American Cancer Society, it is estimated that more than 221,000 Americans will be diagnosed with lung cancer in 2015, and NSCLC accounts for 85% of all lung cancers. It is estimated that approximately 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.