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Priority Review for Atezolizumab as Adjuvant Treatment in Early NSCLC

The FDA has accepted a supplemental Biologics License Application and granted Priority Review for atezolizumab as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumors express PD-L1 >=1 percent, as determined by an FDA-approved test. The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The FDA is expected to make a decision on approval by December 1, 2021.

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This application is based on disease-free survival (DFS) results from an interim analysis of the Phase III IMpower010 study, the first and only Phase III study of a cancer immunotherapy to demonstrate positive results in the adjuvant lung cancer setting. The study showed that treatment with atezolizumab following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death (DFS) by 34 percent (HR=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA NSCLC whose tumors express PD-L1 >=1 percent, compared with best supportive care (BSC). In this population, median DFS was not yet reached for atezolizumab compared with 35.3 months for BSC.


Follow-up on the IMpower010 trial will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, including Stage IB patients, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of interim analysis. Safety data for atezolizumab were consistent with its known safety profile and no new safety signals were identified. Results from the IMpower010 trial were presented at the 2021 ASCO Annual Meeting.


IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of atezolizumab compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either atezolizumab (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA, and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.


Atezolizumab is a monoclonal antibody designed to bind with the protein PD-L1. It is designed to bind to 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, atezolizumab may enable the re-activation of T cells. Atezolizumab may also affect normal cells.


Supplemental New Drug Application for Cabozantinib for Thyroid Cancer Patients

The FDA granted a supplemental New Drug Application (sNDA) for cabozantinib as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate). The FDA granted Priority Review designation and assigned a Prescription Drug User Fee Act target action date of December 4, 2021.


The sNDA is based on the results of COSMIC-311, a Phase III pivotal trial evaluating cabozantinib versus placebo in patients with radioactive iodine-refractory DTC who progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies. At a planned interim analysis, cabozantinib met one of the trial's primary endpoints, demonstrating a significant improvement in progression-free survival versus placebo. In February 2021, the FDA granted Breakthrough Therapy Designation to cabozantinib as a potential treatment for patients with DTC that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) based on these results. Detailed study findings were presented at the 2021 ASCO Annual Meeting and published by The Lancet Oncology in July 2021 (


COSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled Phase III pivotal trial that aimed to enroll approximately 300 patients at 150 sites globally. Patients were randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily. The primary endpoints are progression-free survival and objective response rate.


In the U.S., cabozantinib tablets are approved for the treatment of patients with advanced renal cell carcinoma, patients with hepatocellular carcinoma who have been previously treated with sorafenib, and patients with advanced RCC as a first-line treatment in combination with nivolumab.


Orphan Drug Designation for Sotigalimab for Soft Tissue Sarcoma

Sotigalimab has been granted Orphan Drug Designation for the treatment of soft tissue sarcoma. It is a potentially first-in-class and best-in-class CD40 agonist, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability. In an ongoing Phase II clinical trial, sotigalimab is being evaluated in advanced soft tissue sarcoma in combination with doxorubicin.


The FDA's Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor for various development incentives, including tax credits for qualified clinical testing, up to 7 years of marketing exclusivity for the orphan indication, and waiver of certain FDA fees.


Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. It targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of sotigalimab to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes, and B cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer.


Sotigalimab is currently in Phase II clinical development for the treatment of cancers such as esophageal and gastroesophageal junction cancers, melanoma, rectal cancer, and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy, or a cancer vaccine.