Nivolumab Superior to Dacarbazine for Untreated Metastatic Melanoma

The gist: A recent clinical trial with volunteer patients compared two treatments for metastatic melanoma. It showed that one of the treatments might give longer survival times for people whose tumors do not have mutations in the BRAF gene. This treatment is a drug called nivolumab. It is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer. In the trial, some patients took nivolumab and some took the chemotherapy drug dacarbazine. People who took nivolumab lived a few months longer than people who took dacarbazine. None of the patients had taken any previous treatments for their melanoma.

“Patients with treatment-naive, BRAF wild-type metastatic melanoma treated with nivolumab demonstrated longer OS and PFS than those treated with dacarbazine, according to phase 3 study results presented at the Society for Melanoma Research International Congress.

“Prior research showed nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 immune checkpoint inhibitor — was associated with higher rates of objective response compared with chemotherapy in patients with ipilimumab (Yervoy, Bristol-Myers Squibb)-refractory disease.

“In the current study, Caroline Robert, MD, PhD, head of the Dermatology Unit at the Institut Gustave-Roussy in Paris, and colleagues compared the efficacy of nivolumab vs. chemotherapy in 418 previously untreated patients.

“Researchers assigned patients 3 mg/kg nivolumab every 2 weeks plus a dacarbazine-matched placebo, or 1,000 mg/m2dacarbazine every 3 weeks plus a nivolumab-matched placebo.”

Bristol Immunotherapy Shows Promise in Lung Cancer Trial

The gist: People with advanced squamous non-small cell lung cancer (NSCLC) that worsened despite two rounds of treatment might benefit from additional treatment with the new drug nivolumab, aka Opdivo. In a clinical trial with volunteer patients, 41% of the people who took nivolumab were still alive after one year. That’s much higher than the historical rate of one-year survival for these kinds of patients, which is between 5.5% to 18%. Nivolumab is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer.

“Treatment of advanced squamous cell non-small cell lung cancer (NSCLC) with Bristol-Myers Squibb Co’s experimental immunotherapy nivolumab led to a one-year survival rate of 41 percent in a midstage clinical trial, according to data being presented at a medical meeting.

“While the study called CheckMate-063 did not compare nivolumab with another drug or placebo, the historical one-year survival rate for patients like those in the trial, whose cancer had progressed after treatment with two or more prior therapies, is between 5.5 percent and 18 percent, the company said.

“Nivolumab belongs to a highly promising new class of drugs called PD-1 inhibitors that block a tumor’s ability to camouflage itself, allowing the body’s immune system to recognize and attack the cancer. Merck & Co last month received the first U.S. approval of a drug from the class to treat advanced melanoma – the deadliest form of skin cancer.

“The Phase II findings from CheckMate-063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies,” Dr Suresh Ramalingam, director of Medical Oncology at Winship Cancer Institute of Emory University, said in a statement.”

Immune System-Activating Drugs in Combination Treatments May Be Next Big Thing for Melanoma

Among solid tumors, the curative potential of immunotherapies has been explored most in melanoma. One reason for this is that melanoma tumors often contain so-called immune infiltrates—patches of T cells, the killer cells of the immune system. It seems that these fighter cells arrive at the ‘battlefield’ to target tumor cells for killing, but instead become ‘frozen,’ unable to attack.  How to activate the tumor-killing potential of T cells has been an area of intense and fruitful research, leading to the development of several immunotherapy drugs. Continue reading…

Nivolumab Superior to Chemotherapy in Metastatic Melanoma

The gist: The drug nivolumab (aka Opdivo) appears to be more effective than chemotherapy for certain people with metastatic melanoma. That was the conclusion of a recent clinical trial—a research study with volunteer patients. The study involved people whose disease worsened after treatment with drugs known as anti-CTLA-4 therapies or drugs known as BRAF inhibitors, such as ipilimumab (aka Yervoy).

“Nivolumab induced a greater rate of overall response than chemotherapy in patients with metastatic melanoma who progressed on or after anti-CTLA–4 therapy or treatment with BRAF inhibitors, according to phase 3 study results presented at the European Society for Medical Oncology Annual Congress in Madrid.

“ ‘For those who failed [on] ipilimumab (Yervoy, Bristol-Myers Squibb) and a BRAF inhibitor, there are no therapies known to prolong survival,’ researcher HemOnc Today. ‘This is the first phase 3 study of a PD-1 inhibitor, and first evidence that a PD-1 inhibitor is superior to any other therapy for ipilimumab-refractory melanoma…’

“The next step will be to conduct research designed to evaluate proper ways to combine nivolumab with other agents, Weber said.”

UPDATE 1-Novartis Works with Bristol-Myers Squibb to Test Lung Cancer Drugs

The gist: Combining existing drugs can sometimes result in new, more effective cancer treatments. As we posted on our Need to Know blog today, lung cancer researchers are testing drug combinations that involve immunotherapies—treatments that boost the immune system to fight cancer. Now, two drug companies have announced that they will be testing combinations of their lung cancer drugs. An immunotherapy drug called Opdivo will be combined with targeted drugs. The combinations will be tested in clinical trials with volunteer patients who have late-stage non-small cell lung cancer (NSCLC). It is hoped that the combinations will work better than any of the drugs alone.

“Swiss pharma group Novartis AG said on Monday it would work with Bristol-Myers Squibb Co to test the U.S. drugmaker’s immuno-oncology drug Opdivo in combination with three of its own experimental lung cancer drugs.

“The clinical collaboration will help Novartis advance its efforts in the field of immunotherapy, one of the hottest areas in biotech right now, following the acquisition of CoStim Pharmaceuticals Inc this year, the drugmaker said.

“Novartis currently lags rivals such as Roche, Merck , AstraZeneca and Bristol-Myers in the race to develop immunotherapies – drugs that fight cancer by harnessing the body’s immune system.

“The two companies will test the combination of three molecularly targeted compounds with Bristol-Myers’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in phase I and II studies, Novartis said, adding it would conduct both studies.

” ‘Preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients,’ Alessandro Riva, global head of Novartis oncology development and medical affairs, said in the statement.”

UPDATE 1-Bristol Immune Drug Shows Strong Effect in Melanoma Study

The gist: A new immunotherapy drug called Opdivo has shown promising results for melanoma patients in a clinical trial—a research study with volunteer patients.

“Bristol-Myers Squibb’s immunotherapy drug Opdivo produced markedly improved response rates with fewer toxic side effects compared to chemotherapy in a major melanoma study, underscoring its potential as a new treatment option.

“The data has been keenly awaited since this is the first presentation of results from a pivotal Phase III clinical trial of a promising new class of drugs designed to help the body’s own immune system fight cancer.

“In the study, involving people with advanced melanoma, 32 percent of patients saw their tumours shrink when given Opdivo against 11 percent of those treated with conventional chemotherapy drugs.”

Bristol-Myers Teams with Celgene to Explore New Cancer Treatments

Editor’s note: Two large drug companies are teaming up to combine their drugs to fight breast cancer, pancreatic cancer, and lung cancer. The two drugs are nivolumab (Opdivo) and nab-paclitaxel (Abraxane). The companies will enroll volunteer patients in clinical trials to test how effective the combo is.

“Bristol-Myers Squibb’s determination to get its Opdivo immunotherapy into the U.S. market as a cancer medication took a new turn Wednesday. The firm said it is teaming with biotechnology giant Celgene Corp. to develop a treatment to fight certain types of  tumors using the drug.

“The plan is for Bristol-Myers BMY  to try and combine its immunotherapy treatment with Celgene’s CELG  chemotherapy drug Abraxane in clinical trials with patients suffering from certain types of cancer of the breast, pancreas and lungs.

“Bristol-Myers and Celgene are examining to see whether the combination of the two drugs will produce a stronger tumor combatant than either drug acting alone.”

Bristol to Seek Melanoma Approval for Opdivo Ahead of Expectations

Editor’s note: Opdivo (aka nivolumab) is a drug that has shown promise for treating advanced melanoma in clinical trials with volunteer patients. The company that makes Opdivo, Bristol-Myers Squibb, has submitted an application to the U.S. Food and Drug Administration (FDA) that, if approved, would allow the company to market Opdivo to patients in the U.S. Opdivo is an immunotherapy treatment, meaning that it boosts a patient’s own immune system to fight cancer. Immunotherapies are a promising area of melanoma research, as described by our Chief Scientists on our Need to Know blog.

“Bristol-Myers Squibb Co said on Thursday it plans to seek U.S. marketing approval in the third quarter for its experimental cancer immunotherapy Opdivo as a treatment for advanced melanoma, which would be months sooner than Wall Street expected.

“The company said it would seek approval to market the drug to patients who had previously been treated with Bristol-Myers’ already approved melanoma drug Yervoy, which works through a different mechanism than Opdivo…

“Opdivo works by blocking a protein called PD-1, thereby enabling the immune system to recognize cancer cells and then attack them. It is considered one of Bristol-Myers’ most important experimental drugs, with potential to generate multibillion-dollar annual sales, if approved.”