Atezolizumab is approved by FDA as adjuvant treatment for non-small cell lung cancer

Nov 2021: The Food and Drug Administration has approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumours contain PD-L1 expression on less than 1% of tumour cells, as assessed by an FDA-approved test.

The VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) was also authorised by the FDA today as a companion diagnostic device for selecting patients with NSCLC for adjuvant treatment with Tecentriq.

Disease-free survival (DFS) was the key efficacy outcome measure, as determined by the investigator in the primary efficacy analysis population (n=476) of patients with stage II-IIIA NSCLC with PD-L1 expression on 1% of tumour cells (PD-L1 1% TC). In the atezolizumab arm, median DFS was not reached (95 percent CI: 36.1, NE) compared to 35.3 months (95 percent CI: 29.0, NE) in the BSC arm (HR 0.66; 95 percent CI: 0.50, 0.88; p=0.004).

The DFS HR was 0.43 in a pre-specified secondary subgroup analysis of patients with PD-L1 TC 50% stage II-IIIA NSCLC (95 percent CI: 0.27, 0.68). The DFS HR was 0.87 in an exploratory subgroup study of patients with PD-L1 TC 1-49 percent stage II-IIIA NSCLC (95 percent CI: 0.60, 1.26).

Increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase, as well as hyperkalemia, rash, cough, hypothyroidism, pyrexia, fatigue/asthenia, musculoskeletal pain, peripheral neuropathy, arthralgia, and pruritus, were the most common (ten percent) adverse reactions in patients receiving atezolizumab, including laboratory abnormalities.

For this indication, the recommended atezolizumab dose is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks for up to a year.

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Nishant Mittal (PhD)

+ postsBio ⮌

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

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  Brentuximab vedotin with lenalidomide and rituximab is approved by the USFDA for relapsed or refractory large B-cell lymphoma
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  Mirdametinib is approved by the USFDA for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
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