FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer

Excerpt:

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.

“ ‘In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.’ ”

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Atezolizumab Continues To Show Potential in NSCLC

“With atezolizumab (MPDL3280A) showing great potential as a treatment for patients with non–small cell lung cancer (NSCLC) in two particlar studies, we sat down with Chandra P. Belani, MD, to talk more about the treatment.

“The PD-L1 inhibitor received a breakthrough therapy designation from the FDA based on early-stage studies as a potential treatment for patients with PD-L1–positive NSCLC, post-progression on prior therapies such as chemotherapy and targeted therapies. Belani, Miriam Beckner Distinguished Professor of Medicine, Penn State Milton S. Hershey Medical Center, deputy director, Penn State Hershey Cancer Institute, said in an interview with Targeted Oncology, that the acitivity the treatment shows is impressive.”


Atezolizumab/Nab-Paclitaxel Combo Shows High Response Rates in TNBC

“Upfront treatment with the PD-L1 inhibitor atezolizumab (MPDL3280A) plus nab-paclitaxel (Abraxane) showed a confirmed objective response rate (ORR) of 66.7% in patients with metastatic triple-negative breast cancer (TNBC), according to data presented at the 2015 San Antonio Breast Cancer Symposium.

“In the phase Ib study, atezolizumab plus nab-paclitaxel was explored across several lines of treatment regardless of PD-L1 status for patients with metastatic TNBC. In the second-line setting, the confirmed ORR was 25% and in the third-line and beyond the ORR was 28.6%. Across the full trial, the ORR was 41.7%.

“ ‘For the efficacy, we saw a very high response rate, which is extremely exciting and encouraging,’ said lead investigator Sylvia Adams, MD, associate professor of Medicine, NYU Perlmutter Cancer Center. ‘The combination was well-tolerated without additive toxicity. We saw only toxicity that was predictable for the single agents alone.’ “


Roche Buoyed by Early Data on Atezolizumab in Advanced Melanoma

“Swiss drugmaker Roche released on Monday what it called encouraging early data on cancer drug atezolizumab in combination therapy for treating a form of advanced melanoma.

“A phase Ib study of atezolizumab (MPDL3280A), used in combination with the BRAF inhibitor Zelboraf for previously untreated BRAFV600 mutation-positive inoperable or metastatic melanoma, showed adverse events were “manageable and generally reversible”, it said.

“It showed the combination resulted in an objective response rate of 76 percent of people, including three complete responders.”


Roche's Atezolizumab Shrinks Tumors in Lung, Bladder Cancer

“Roche Holding AG, the world’s biggest maker of cancer drugs, said its experimental medicine atezolizumab shrank lung and bladder tumors in separate studies that the company plans to use to apply for U.S. regulatory approval.

“A lung cancer study dubbed Birch found the drug shrank tumors in as many as 27 percent of patients, Roche said Sunday in a statement. An update from another study called Poplar in patients whose lung cancer has returned after previous treatment showed those who had received atezolizumab lived 2.9 months longer than those who got chemotherapy. Both studies will be presented at the European Cancer Congress in Vienna.

“The company has said it plans to submit the drug for U.S. regulatory approval next year. Roche is trailing Bristol-Myers Squibb Co., whose Opdivo was approved for lung cancer in March. Both medicines are part of a new category of therapies that harness the immune system to attack cancer. They may become a $100 billion market by 2020, according to UBS AG.”


Pivotal Phase II Study Showed Roche's Investigational Immunotherapy Atezolizumab Shrank Tumours in People with a Specific Type of Lung Cancer

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that in the large pivotal Phase II study, BIRCH, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) met its primary endpoint and shrank tumours (objective response rate; ORR) in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death Ligand-1). The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine. Adverse events were consistent with what has been previously observed for atezolizumab.

“ ‘We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study, which is particularly meaningful for people who had received several prior treatments,’ said Sandra Horning, M.D., Chief Medical Officer and head of Global Product Development. ‘We plan to present results at an upcoming medical meeting and will discuss these data as well as results from our other lung cancer studies with health authorities to bring this medicine to patients as quickly as possible.’ “


Video: Dr. Nanda on Immunotherapy in Metastatic TNBC

“Rita Nanda, MD, assistant professor of Medicine, associate director, Breast Medical Oncology, The University of Chicago Medicine, discusses the efficacy of pembrolizumab and atezolizumab for the treatment of patients with metastatic triple-negative breast cancer (TNBC).

“Response rates seen with the two immunotherapy agents in two separate clinical trials in a heavily pretreated metastatic population was slightly under 20%, Nanda explains. This is significant due to how heavily pretreated these patients were, she adds.

“Furthermore, these responses were found to be durable and lasted up to 40 weeks. Both pembrolizumab and atezolizumab were shown to be well-tolerated. Patients experienced low-grade toxicities that were easily managed.”

Click through to watch the video.


Adding Atezolizumab to Chemotherapy Shows Promise in NSCLC

“The anti–PD-L1 agent atezolizumab (MPDL3280A) was recently investigated for safety and efficacy in combination with platinum-based doublet chemotherapy in treatment-naïve patients with advanced non–small cell lung cancer (NSCLC). Results from the phase Ib study were presented at the 2015 ASCO Annual Meeting.

“The multiple-arm study looked at MPDL3280A with a different chemotherapy backbone in each arm: carboplatin plus paclitaxel (Arm C; n = 8) carboplatin plus pemetrexed (Arm D; n = 14) or carboplatin plus nab-paclitaxel (Arm E; n = 15).

“Across all arms, the overall response rate (ORR) was 67% (48%-82%), with 60% ORR (19%-92%) in Arm C (3 partial responses [PRs]), 75% (45%-93%) in Arm D (9 PRs), and 62% (33%-83%) in Arm E (6 PRs, 2 complete responses).

“Regarding the safety profile, the researchers concluded that the combination regimens were well tolerated. The most frequent all-grade adverse events included those commonly associated with chemotherapy, such as nausea (Arms C and D, 50%; Arm E, 73%), fatigue (Arm C, 38%; Arm D, 36%; Arm E, 73%) and constipation (Arm C, 25%; Arm D, 71%; Arm E, 27%).

“OncLive spoke with Stephen Liu, MD, lead author on the study and assistant professor, Division of Hematology and Oncology, Georgetown University, to better understand the results and purpose of the uniquely designed trial, and how oncologists may need to rethink trial design when investigating similar novel agents.”


[Video] Dr. Spira on Atezolizumab in the POPLAR Study for NSCLC

“Alexander Spira, MD, PhD, FACP, medical oncology, hematology, Virginia Cancer Specialists, discusses the POPLAR study for non-small cell lung cancer (NSCLC).

“The phase II study randomized patients with NSCLC to atezolizumab (MPDL3280A) or docetaxel in the second- or third-line setting. Patients who were administered the anti-PD-L1 agent were treated until practitioners determined there was no longer a benefit, Spira says. Patients in the docetaxel arm were treated until disease progression.

“At the interim analysis, which is not yet final, there was improved survival with atezolizumab. A correlation was also found between PD-L1 expression and efficacy of the drug. A phase III study is ongoing. Results from this study could also potentially identify a biomarker, Spira adds.”