Opdivo (nivolumab), developed by Bristol-Myers Squibb, is a prescription medicine used to treat advanced stage non-small cell lung cancer (NSCLC) that has spread or grown and not responded, or is no longer responding to platinum-based chemotherapy agents.

The U.S. Food and Drug Administration (FDA) granted Opdivo breakthrough therapy, priority review, and orphan drug designation because preliminary clinical evidence suggested the drug may offer a substantial improvement over available therapies.

How Opdivo works

Opdivo is a human antibody that works with the immune system to treat cancer.

T-cells are white blood cells involved in the immune response. They normally are able to recognize cancer cells as abnormal and kill them. To prevent T-cells from attacking the body’s healthy cells, there are checkpoints, one of which is the PD-1 pathway.

T-cells normally produce receptor proteins called programmed cell death (PD-1), which blocks killing a cell when it interacts with ligands (small molecules that, in this case, are attached to other cells) called PD-L1 and PD-L2. Some tumor cells produce these ligands to disrupt the PD-1 pathway and therefore evade T-cells.

Opdivo works by binding to PD-1 receptor and blocking the interaction with its ligands, PD-L1 and PD-L2, which allows T-cells to find and destroy the cancer cells.

As it acts by removing an immune system checkpoint, Opvido also may cause T-cells to attack healthy cells.

Opdivo in clinical trials

Bristol-Myers Squibb has a broad, global development program to study Opdivo as monotherapy or in combination with other drugs in more than 35 clinical trials worldwide. Those trials include more than 7,000 patients with multiple tumor types.

Opdivo was approved by the FDA for patients with melanoma who did not respond to treatment or whose cancer has spread to other parts of the body following treatment with other cancer drugs, based on data from the Phase 3 clinical trial CheckMate-037  (NCT01721746). The trial studied 405 patients with advanced melanoma, comparing the effect of Opvido with that of other chemotherapy drugs, such as DTIC-Dome (dacarbazine), or intravenous carboplatin plus Taxol (paclitaxel). The results showed that Opdivo demonstrated a better response rate than chemotherapy drugs and caused fewer serious adverse effects.

Another Phase 3 trial (NCT01721772) called CheckMate-066, assessed Opdivo in 418  patients with advanced melanoma. Treatment with Opdivo demonstrated an improvement in survival rate.

CheckMate-214 (NCT02231749),, also a Phase 3 study evaluated the combination of Opdivo plus Yervoy (ipilimumab) versus Sutent (sunitinib) in patients with previously untreated advanced or metastatic renal cell carcinoma. The overall survival results from this trial highlighted the potential of the combination of Opdivo and Yervoy as a new treatment option for advanced renal cell carcinoma patients.

CheckMate-017 and CheckMate-057 (NCT01642004 and NCT01673867, respectively) are two pivotal Phase 3 clinical trials that evaluated Opdivo versus Taxotere (docetaxel) in patients with squamous NSCLC and non-squamous NSCLC. Data from these two trials reinforce the survival benefit demonstrated with Opdivo for this group of patients even after three years. The results represent the longest follow-up data reported for a PD-1 inhibitor versus chemotherapy in NSCLC.

CheckMate-238 (NCT02388906) is an ongoing Phase 3 study of Opdivo versus Yervoy in patients who have undergone complete resection of stage 3b/c or stage 4 melanoma and demonstrated a significant improvement in recurrence-free survival (the length of time after treatment that the patient survives  without any signs or symptoms of cancer) compared to Yervoy.

Opdivo continues to be explored for the treatment of several cancer types, including NSCLC and renal cell carcinoma.

Other information

Opdivo is indicated as an intravenous infusion for the treatment of advanced melanoma, NSCLC, and renal cell carcinoma, classical Hodgkin’s lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, and certain types of metastatic colorectal cancers.

The most common side effects associated with the use of Opdivo are fatigue, shortness of breath, muscle pain, decreased appetite, cough, nausea, and constipation. Serious side effects may include inflammation of the lungs, colon (which may lead to tears or holes in the colon), liver, kidneys (which may lead to kidney failure), and brain. Use of the drug also may lead to hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas), skin problems, problems in other organs, and severe infusion-related reactions.


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