Nivolumab (Opdivo) demonstrates survival benefit in squamous and non-squamous non-small cell lung cancer (NSCLC)

October 11, 2015 – In recent months, Nivolumab (Opdivo), a human IgG4 anti-PD-1 monoclonal antibody which targets the PD-1 receptor, had been approved first for the treatment of unresectable  or advanced (metastatic) melanoma and secondly for the treatment of advanced (metastatic) squamous non-small cell lung cancer (NSCLC). This week, the American  Food and Drug Administration approved Nivolumab (Opdivo) to also treat patients with advanced (metastatic) squamous non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

Lung cancer is one of the leading cause of cancer death in the US and worldwide. The most common type of lung cancer, non-small cell lung cancer (NSCLC), is further divided into two main types named for the kinds of cells found in the cancer, namely squamous cells and non-squamous cells (which includes adenocarcinoma). Nivolumab (Opdivo) works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Nivolumab (Opdivo) may help the body’s immune system fight the cancer cells. The approval of Nivolumab (Opdivo) earlier this year was for the treatment of patients with advanced squamous NSCLC whose disease progressed during or after platinum-based chemotherapy. The current approval now expands the use of Opdivo to also treat patients with non-squamous NSCLC.

The effectiveness of Nivolumab (Opdivo) for this indication was demonstrated in an international, open-label, randomized study of 582 participants with advanced non-squamous NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy. Participants were treated with Nivolumab (Opdivo) or docetaxel. The primary endpoint was overall survival, and the secondary endpoint was objective response rate (the percentage of Non-Squamous NSCLCpatients who experienced complete or partial shrinkage of their tumors). Those treated with Nivolumab (Opdivo) lived an average of 12.2 months compared to 9.4 months in those treated with docetaxel. Additionally, 19 percent of those treated with Nivolumab (Opdivo) experienced a complete or partial shrinkage of their tumors, an effect that lasted an average of 17 months, compared to 12 percent among those taking docetaxel, which lasted an average of six months.

According to Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, there remains still a lot to be learned about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types. Thus, while patients who received Nivolumab (Opdivo) lived longer than those who received docetaxel across the study, an evaluation of samples from a subgroup of patients’ tumors suggests that the level of PD-L1 expression in NSCLC tumors may help identify patients who are more likely to live longer due to treatment with Nivolumab (Opdivo). Therefore the FDA also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels and help physicians determine which patients may benefit most from treatment with Nivolumab (Opdivo).

Another drug called Pembrolizumab (Keytruda) also targets the PD-1/PD-L1 pathway. It was approved just last week for treating NSCLC specifically for patients whose tumors expressed PD-L1. Thasso Post had a recent report on Pembrolizumab (Keytruda).

As one might expect from immune checkpoint modulating drugs, Nivolumab (Opdivo) comes with a rather serious and complicated clinical safety profile, which in some patients simply may lead to therapy terminating events with sometimes fatal outcome. In an earlier article in Thasso Post, inclusive the comment section to this article, these clinical safety concerns with respect to Opdivo have substantiated.

Follow below a commentary by Corey Langer, MD, on the immune checkpoint therapy approach involving  Nivolumab (Opdivo):

Tags: , , , , , , , , , , ,
About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Your opinion

Comment

@peepso_user_30549(sajibuni)
Hello Everyone out there,I am here to give my testimony about a Herbalist doctor who helped me . I was infected with HERPES SIMPLEX VIRUS five years ago, i went to many hospitals for cure but there was no solution, so I was thinking how can I get a solution out so that my body can be okay. One day I was in the river side thinking where I can go to get solution. so a lady walked to me telling me why am I so sad and i open up all to her telling her my problem, she told me that she can help me out, she introduce me to a doctor who uses herbal medication to cure HERPES SIMPLEX VIRUS and gave me his email, so i mail him. He told me all the things I need to do and also give me instructions to take, which I followed properly. Before I knew what is happening after two weeks the HERPES SIMPLEX VIRUS that was in my body got vanished . so if you are also heart broken and also need a help, you can also email him at dr.chalaherbalhome@gmail.com or Contact him today on whatsapp number… Read more
6 months ago 6 months ago

thasso: conditions

thasso: newest tweets

thasso: recent comments

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • New type of taste cell discovered in taste buds August 13, 2020
    Our mouths may be home to a newly discovered set of multi-tasking taste cells that—unlike most known taste cells, which detect individual tastes—are capable of detecting sour, sweet, bitter and umami stimuli. A research team led by Kathryn Medler at the University at Buffalo reports this discovery in a study published 13th August in PLOS […]
  • Researchers discover genetic link to predict positive response to immunotherapy in patient August 13, 2020
    A Singapore team led by clinician-scientists and researchers from the National Cancer Centre Singapore (NCCS) discovered a genetic link to better predict treatment response for relapsed/refractory patients with natural-killer T-cell lymphoma (NKTCL), a highly aggressive form of blood cancer. The team performed whole-genome sequencing, to identify mutation in PD-L1 gene as a reliable biomarker to […]
  • Evolution and everyday stress have led to disproportionate suffering among women August 13, 2020
    We're 100% behind knowledge-based research, but sometimes you really do have to question evolution!
  • A cancer mystery more than 40 years old is solved thanks to epigenetics August 12, 2020
    Before the first oncogene mutations were discovered in human cancer in the early 1980s, the 1970s provided the first data suggesting alterations in the genetic material of tumors. In this context, the prestigious journal Nature published in 1975 the existence of a specific alteration in the transformed cell: an RNA responsible for carrying an amino […]
  • Combining genetic information with EMRs to pinpoint childhood epilepsies August 11, 2020
    A team of researchers at Children's Hospital of Philadelphia (CHOP) affiliated with the CHOP Epilepsy Neurogenetics Initiative (ENGIN) further bridged the gap between genomic information and clinical outcome data by systematically linking genetic information with electronic medical records, focusing on how genetic neurological disorders in children develop over time. The findings were published today in […]
  • Liquid crystals that can replace color shifting ink in preventing counterfeiting August 14, 2020
    A research team in Korea has developed a material that may potentially replace color shifting ink in prevention of forgery of bank notes, ID cards, and so on. A team headed by Dr. Sang-seok Lee from the Functional Composite Material Research Center of the Korea Institute of Science and Technology successfully developed a technology to […]
  • Sounds of action: Using ears, not just eyes, improves robot perception August 14, 2020
    People rarely use just one sense to understand the world, but robots usually only rely on vision and, increasingly, touch. Carnegie Mellon University researchers find that robot perception could improve markedly by adding another sense: hearing.
  • Research captures how human sperm swim in 3D August 13, 2020
    Using state-of-the-art 3D microscopy and mathematics, Dr Hermes Gadêlha from the University of Bristol, Dr Gabriel Corkidi and Dr Alberto Darszon from the Universidad Nacional Autonoma de Mexico, have reconstructed the movement of the sperm tail in 3D with high-precision.
  • Global deaths due to smokeless tobacco are up by a third, according to new study August 13, 2020
    The number of deaths globally due to smokeless tobacco has gone up by a third in 7 years to an estimated 350,000 people, a new study suggests.
  • Employers reject transgender people August 13, 2020
    Employers in Sweden more often reject job applications from transgender people -- especially in male-dominated occupations. Moreover, transgender people face discrimination from two different grounds for discrimination. This is according to a study from Linköping University that was recently published in the journal Labour Economics.
Top