Syndicate content

FDA Grants Roche’s Tecentriq, in Combination with Abraxane, Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer; First Cancer Immunotherapy Regimen Approved for Breast Cancer

On March 11, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) (an anti-PD-L1 monoclonal antibody), plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]), for the treatment of adults with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. “The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.” This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. This accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq, plus nab-paclitaxel, significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone (median PFS=7.4 vs. 4.8 months; HR=0.60, 95% CI: 0.48-0.77, p<0.0001) in PD-L1-positive patients with unresectable, locally advanced or metastatic TNBC, who had not received prior chemotherapy for metastatic disease. Overall survival (OS) results were immature with 43% of events in all randomized patients (intent-to-treat; ITT), and further data will be shared with the FDA and presented at an upcoming medical meeting. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The most common Grade 3-4 side effects (≥2%) with Tecentriq plus nab-paclitaxel were low white blood cells, tingling or numbness in the hands and feet, neutrophil count decreased, feeling tired, low red blood cells, low blood potassium level, pneumonia, and increased blood level of a liver enzyme (AST). The most common side effects (≥20 %) were hair loss, feeling tired, tingling or numbness in the hands and feet, nausea, diarrhea, low red blood cells, constipation, cough, headache, low white blood cells, decreased appetite, and vomiting.
IMpassion130 STUDY

The IMpassion130 study is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety, and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer.

The study enrolled 902 people who were randomized equally (1:1). The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) in the ITT population and in the PD-L1-positive population and OS in the ITT population. OS results were immature in the ITT population. Secondary endpoints include objective response rate and duration of response.

TRIPLE-NEGATIVE BREAST CANCER

Breast cancer is the most common cancer among women, with more than 2 million cases diagnosed worldwide each year. TNBC represents 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. It is defined by the lack of expression and/or amplification of the targetable receptors for estrogen, progesterone, and HER2 amplification. Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.

ROCHE IN BREAST CANCER

Roche says it has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. The company claims that its medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer.

As understanding of breast cancer biology rapidly improves, Roche is working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

The company’s targeted medicines Herceptin, Perjeta, and Kadcyla are continuing to transform the treatment of early and advanced HER2-postive breast cancer and, through its Tecentriq and ipatasertib clinical programs, Roche hopes to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.

TECENTRIQ

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 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 has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines, and various chemotherapies across a broad range of cancers.

Tecentriq is already approved in the European Union, the United States, and more than 85 countries, for people with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

ROCHE IN CANCER IMMUNOTHERAPY

For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, the company says it is investing more than ever in its effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying seminal research in immune tumor profiling within the framework of the Roche-devised cancer immunity cycle, the company believes it is accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer.

The company’s cancer immunotherapy development program takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients

To learn more about the Roche approach to cancer immunotherapy please follow this link (http://www.roche.com/research_and_development/what_we_are_working_on/onc...).

[Roche press release (March 11, 2019)] [Genentech press release (March 8, 2019)]

[Reuters article] [Medscape article] [STAT News article by Sharon Begley] [Healio article]