Atezolizumab/Bevacizumab Approved for Unresectable Hepatocellular Carcinoma

The FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.) in combination with bevacizumab (Avastin®, Genentech, Inc.) for patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who have not previously received systemic therapy. The approval was based on IMbrave150 (NCT03434379), a phase 3 trial that enrolled 501 patients with unresectable HCC. Patients were randomized in a 2:1 ratio to receive atezolizumab 1,200 mg administered intravenously followed by be...

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Atezolizumab for Previously Treated Non-Small Cell Lung Cancer: Julien Mazières, MD, PhD

For patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC), effective treatment options with minimal toxicity remain limited. In this interview with i3 Health, Julien Mazières, MD, PhD, Professor of Respiratory Medicine at Toulouse University Hospital, discusses his collaborative research finding that atezolizumab increases long-term overall survival compared with docetaxel, regardless of histology, subsequent immunotherapy, and programmed death ligand...

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Atezolizumab Improves Overall Survival in Non-Small Cell Lung Cancer

In patients with previously treated non-small cell lung cancer (NSCLC), atezolizumab increases overall survival compared with docetaxel, regardless of programmed death ligand 1 (PD-L1) status, histology, and subsequent immunotherapy, according to a new study published in the Journal of Thoracic Oncology. "In clinical trials conducted with immunotherapy, the benefit to patients is usually sustained over time," write the investigators, led by first author Julien Mazieres, MD, PhD, Professor of Res...

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Atezolizumab Combo Effective in EGFR-Mutated Non-Small Cell Lung Cancer

The addition of atezolizumab to bevacizumab/carboplatin/paclitaxel (BCP) significantly prolongs overall survival in patients with non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, according to results of a final efficacy analysis presented this week at the European Medical Society for Oncology (ESMO) Virtual Congress 2020. "Atezolizumab inhibits programmed death-ligand 1 (PD-L1) to restore anti-cancer immunity; bevacizumab may enhance atezoli...

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FDA Alert: Atezolizumab/Paclitaxel Ineffective for Triple-Negative Breast Cancer

The FDA has issued an alert regarding the combination of atezolizumab (Tecentriq®, Genentech) and paclitaxel for the treatment of patients with previously untreated, inoperable locally advanced or metastatic triple-negative breast cancer (TNBC). In addition to being ineffective, atezolizumab/paclitaxel can negatively impact overall survival. While atezolizumab/paclitaxel is not approved for the treatment of breast cancer, atezolizumab in combination with paclitaxel protein-bound particles, also ...

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Atezolizumab Triplet Therapy for BRAF V600-Mutant Melanoma: Paolo A. Ascierto, MD

Recently, the FDA approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) and cobimetinib (Cotellic®, Genentech) for the treatment of BRAF V600-mutant advanced melanoma. In this interview with i3 Health, Paolo A. Ascierto, MD, principal investigator of the IMspire150 trial, on which the approval was based, discusses the approval's significance and the most promising research developments in the treatment of BRAF...

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Atezolizumab Combo Approved in BRAF V600-Mutant Melanoma

The FDA has approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with cobimetinib (Cotellic®, Genentech) and vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) for the treatment of BRAF V600-mutated advanced melanoma. The approval was granted under a supplemental Biologics License Application (sBLA) with priority review. The approval was based on data from the double-blind, international phase 3 IMspire150 trial (NCT02908672), for which 514 patients with unresecta...

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Atezolizumab for PD-L1–High Non-Small Cell Lung Cancer: David Spigel, MD

Atezolizumab (Tecentriq®, Genentech, Inc.) was recently approved by the FDA for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with high expression of programmed death ligand-1 (PD-L1). The approval was based on IMpower110, a phase 3 trial led by David Spigel, MD, Chief Scientific Officer and Director of the Lung Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee. In this interview with i3 Health, Dr. Spigel discusses the s...

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Atezolizumab Approved for PD-L1–High Non-Small Cell Lung Cancer

The FDA has expanded the approval of atezolizumab (Tecentriq®, Genentech, Inc.) to include adults with untreated metastatic non-small cell lung cancer (NSCLC) with high expression of programmed death ligand-1 (PD-L1). High PD-L1 expression is defined as PD-L1 staining on at least 50% of tumor cells or tumor-infiltrating immune cells covering at least 10% of the tumor area. In addition, the FDA has approved a companion diagnostic device, the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, I...

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Atezolizumab Plus nab-Paclitaxel and Carboplatin FDA Approved for Metastatic NSCLC

Atezolizumab (Tecentriq®, Genentech Inc.) in combination with nab-paclitaxel and carboplatin is now FDA approved as first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Atezolizumab, previously approved to treat extensive-stage small cell lung cancer, metastatic urothelial carcinoma, and metastatic triple-negative breast cancer, works as a monoclonal antibody and stimulates the immune system by block...

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Atezolizumab/Bevacizumab for Advanced Renal Cell Carcinoma: Bradley McGregor, MD, and Toni Choueiri, MD

While metastatic renal cell carcinoma (RCC) has a five-year survival rate of only 10%, patients whose tumors have variant histology or sarcomatoid differentiation face an even more dismal outlook, with limited treatment options. In a study now published in the Journal of Clinical Oncology, a team of researchers led by Bradley McGregor, MD, and Toni Choueiri, MD, reported that atezolizumab in combination with bevacizumab significantly increased progression-free survival and improved outcomes in p...

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Atezolizumab Approved for Metastatic Nonsquamous NSCLC

After granting Priority Review, the FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.), a monoclonal antibody, to be used in combination with carboplatin/paclitaxel/bevacizumab (CPB) for patients with previously untreated metastatic nonsquamous, non-small cell lung cancer (NSCLC) without EGFR or ALK tumor mutations. The approval was based on the open-label, three-arm IMpower150 trial (NCT02366143), for which patients were randomized 1:1:1 to a regimen of atezolizumab plus CPB, a regimen...

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Mark Socinski, MD: First-Line Atezolizumab in Metastatic NSCLC

Mark A. Socinski, MD.

In an interview with i3 Health, Mark A. Socinski, MD, shares insights regarding the recent FDA approval of atezolizumab (Tecentriq®, Genentech, Inc.) in combination with carboplatin/paclitaxel/bevacizumab for patients with previously untreated metastatic nonsquamous, non-small cell lung cancer (NSCLC) without EGFR or ALK tumor mutations. Dr. Socinski, Executive Medical Director and Medical Oncologist at the Florida Hospital Cancer Institute, was the lead researcher on the IMpower150 trial (NCT02366143), which served as the basis for the FDA approval.

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First Checkpoint Immunotherapy Approved in Breast Cancer

The FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.) in combination with nab-paclitaxel as a first-line treatment for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death-ligand 1 (PD-L1). This is the first FDA approval of an immune checkpoint inhibitor for any type of breast cancer. It is also a substantial development for patients with TNBC, a highly aggressive subtype that lacks many of the targeted the...

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Immunotherapy in Triple-Negative Breast Cancer: An Interview With Leisha Emens, MD, PhD

​The FDA's approval of atezolizumab (Tecentriq®, Genentech, Inc.) in combination with nab-paclitaxel for patients with previously untreated unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) expressing programmed death-ligand 1 (PD-L1) represents the first approval of an immune checkpoint inhibitor for breast cancer. In addition, it is an important development for patients with TNBC, which lacks many of the targeted therapies that can be used in other types of breas...

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First-Line Atezolizumab Approved: Extensive-Stage SCLC

​The FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.) in combination with carboplatin and etoposide as first-line treatment for patients with extensive-stage (ES) small cell lung cancer (SCLC). This is the first immunotherapy-based combination to be approved in the initial treatment of ES-SCLC. Extensive-stage SCLC has spread widely throughout the lung, to the other lung, to lymph nodes on the other side of the chest, to the fluid around the lung, or to other areas in the body, such a...

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