Opdivo Approved for Squamous Lung Cancer

“Bristol-Myers Squibb (BMY) secured an expanded U.S. approval Wednesday for the use of its checkpoint inhibitor Opdivo to treat a form of advanced lung cancer.

“The new Opdivo approval covers patients with squamous non-small cell lung cancer no longer responsive to chemotherapy, according to an announcement made by the FDA. In December, Bristol’s drug was approved initially to treat skin cancer.

“The FDA moved exceptionally fast expanding Opdivo’s approval. Bristol said the lung cancer application was accepted last week with an approval decision expected in June.

“The worldwide commercial market for squamous cell lung cancer patients tops $3 billion, according to an analysis by Barclays.”


U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (Nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer

“Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab)for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015.

“In the U.S., lung cancer is one of the leading causes of cancer deaths. Non-small cell lung cancer, one of the most common types accounting for approximately 85 percent of cases, includes three main subtypes including squamous NSCLC. Squamous NSCLC accounts for approximately 25 to 30 percent of all lung cancers.

“ ‘With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,’ said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb. ‘As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.’ ”


Companies Work Together to Address Need for a Test to Identify Lung Cancer Patients Who Might Benefit from Opdivo

“Agilent subsidiary Dako and Ono Pharmaceutical are working together to investigate and advance a diagnostic test that will identify which non-small cell lung cancer patients are likely to respond to Opdivo (nivolumab).

” ‘This test is being investigated for its diagnostic utility,’ the companies said, in order to identify best responders to Opdivo. The drug works by inhibiting PD-1, a protein that impedes the body’s ability to launch an immune attack against cancer cells.

“The US Food and Drug Administration in December granted accelerated approval of Opdivo as a treatment for advanced or unresectable melanoma patients who are no longer responding to other drugs. Additionally, Ono also received regulatory approval in Japan for Opdivo for the same indication in July.

“In the US, Bristol-Myers Squibb sells Opdivo. BMS holds global development and commercialization rights to Opdivo, except in Japan, South Korea, and Taiwan, where Ono retains all rights for the compound.”


Immune System-Boosting Drug Combo to Begin Testing in Patients in New Clinical Trial

The gist: A new drug combination will be tested in patients with advanced non-small cell lung cancer (NSCLC), metastatic melanoma (MEL), colorectal cancer (CRC), ovarian cancer, or head and neck squamous cell carcinoma (SCCHN). The treatment combines the drugs varlilumab and nivolumab (Opdivo). Both drugs are immunotherapies; they activate a patient’s own immune system to fight cancer. The trial will test the safety of the combo and see how well it works.

“Celldex Therapeutics, Inc. (NASDAQ: CLDX) and Bristol Myers-Squibb (NYSE: BMY) today announced the initiation of a Phase 1/2 dose escalation and cohort expansion study examining the investigational combination of varlilumab, Celldex’s CD27 targeting investigational immune-activating antibody and Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab). The study will be conducted in adult patients with advanced non-small cell lung cancer (NSCLC), metastatic melanoma (MEL), colorectal cancer (CRC), ovarian cancer, and head and neck squamous cell carcinoma (SCCHN). Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. This study will evaluate the safety and tolerability of the combination and address the hypothesis that the combination of these two mechanisms enhance the anti-tumor activity compared to either agent alone. Celldex is responsible for conducting the study and development costs will be shared.”


First PD-1 Inhibitor in Lung Cancer May Soon Be Approved

The gist: This Q&A with an oncologist gives a good overview of a promising immunotherapy for non-small cell lung cancer (NSCLC). Immunotherapies are treatments that boost a patient’s own immune system to fight cancer. Based on good clinical trial results, the U.S. Food and Drug Administration (FDA) might soon approve a drug called nivolumab (Opdivo) for certain lung cancer patients. If it’s approved, doctors could prescribe it for patients with advanced, squamous NSCLC who have already tried two other treatments. Opdivo is a specific kind of immunotherapy called a PD-1 inhibitor.

“Immune checkpoint inhibitors targeted against PD-1 and its ligand PD-L1 have rapidly advanced as treatments for patients with melanoma and non–small cell lung cancer (NSCLC), following their initial debut in 2012.

“In the past 4 months alone, the PD-1 inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) have each gained separate approvals as treatments for patients with advanced melanoma. Additionally, in mid-January, phase III findings from the CheckMate-017 study demonstrated that nivolumab extended overall survival compared with docetaxel in patients with pretreated squamous cell NSCLC.

“Based on these findings and those from phase II studies, Bristol-Myers Squibb (BMS) is currently in the process of submitting a New Drug Application to the FDA for nivolumab as a third-line treatment for patients with squamous cell NSCLC. Furthermore, several phase III studies are currently examining the agent across a variety of tumor types.”


Nivolumab Better than Chemotherapy in Untreated Melanoma

The gist: People with advanced melanoma who have not yet been treated might benefit from the drug nivolumab (Opdivo). In December, the U.S. Food and Drug Administration (FDA) approved Opdivo for people who had tried other treatments unsuccessfully. Now, a new clinical trial shows that patients without prior treatment survive longer on Opdivo than chemotherapy.

“The PD-1 inhibitor nivolumab significantly increased overall survival compared with chemotherapy in patients with previously untreated metastatic melanoma without a BRAF mutation. In addition, the drug more than doubled the progression-free survival among these patients.

“ ‘The risk of death decreased by 58% with nivolumab, as compared with dacarbazine, among previously untreated patients with advanced melanoma,’ wrote study author Caroline Robert, MD, PhD, of INSERM Unité 981, Gustave Roussy, and colleagues. ‘The survival benefit was consistent across all the prespecified subgroups, including patients with poor prognostic factors.’

“The results of the phase III double-blind study were published in the January 22 issue of the New England Journal of Medicine.”


New Drug Combo to Begin Testing in Advanced NSCLC

The gist: A new drug combination will soon be tested in advanced non-small cell lung cancer (NSCLC). The treatment combines the drugs nivolumab (Opdivo) and galunisertib (LY2157299). Both drugs are immunotherapies, meaning they are meant to boost the immune system to fight cancer.

“Bristol-Myers Squibb Company (NYSE:BMY) and Eli Lilly and Company (NYSE:LLY) announced today a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) in combination with Lilly’s galunisertib (LY2157299). The Phase 1/2 trial will evaluate the investigational combination of Opdivo and galunisertib as a potential treatment option for patients with advanced (metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma and non-small cell lung cancer.

“Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. Galunisertib (pronounced gal ue” ni ser’tib) is a TGF beta R1 kinase inhibitor that in vitro selectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body. This collaboration will address the hypothesis that co-inhibition of PD-1 and TGF beta negative signals may lead to enhanced anti-tumor immune responses than inhibition of either pathway alone.”


Opdivo so Much Better than Chemotherapy for NSCLC That a Clinical Trial Is Stopped Early

The gist: Researchers found that the drug nivolumab (Opdivo) worked so much better than chemotherapy for certain lung cancer patients that they stopped a clinical trial early. The researchers were testing Opdivo in people with advanced, squamous cell non-small cell lung cancer (NSCLC) that had been previously treated. Opdivo is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer.

Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase 3 study evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company will share these data – which for the first time indicate a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer – with health authorities.

“CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -017 data and work with investigators on the future presentation and publication of the results.”


FDA Approves Opdivo for Advanced Melanoma

“The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.

“Melanoma is the fifth most common type of cancer in the United States. It forms in the body’s melanocyte cells, which develop the skin’s pigment. The National Cancer Institute estimates that 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.

“Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.”