NHS Patients Barred from BMS' Opdivo, Roche's Kadcyla

“NICE is planning to bar patients with a particular form of lung cancer from access to Bristol-Myers Squibb’s ground-breaking immunotherapy Opdivo on the NHS in England and Wales.

“Opdivo (nivolumab) is the first in a new class of medicines, called PD-1 immune checkpoint inhibitors, to be licensed for use in squamous pre-treated lung cancer patients, and is currently available in the UK to some patients through the Early Access to Medicines Scheme.”


New Promising Drugs for Small Cell Lung Cancer


Any type of advanced lung cancer is bad news, but a diagnosis of small cell lung cancer (SCLC) is a particularly grim one to receive. About 30 years have passed since any new treatments for SCLC were developed, and patients’ responses to standard chemotherapy with etoposide and cisplatin are short-lived. Hopefully, this will change soon.

We begin this post with the immune checkpoint inhibitors, a type of immunotherapy that is explored in seemingly every type of cancer, including SCLC. Reports from two clinical trials of these drugs were recently made available at two meetings on lung cancer treatment. Continue reading…


New Long-Term Data on Opdivo and the Opdivo + Yervoy Regimen Shows Survival Benefit Across Lines of Therapy in Advanced Melanoma

“Bristol-Myers Squibb Company (NYSE:BMY) today announced new long-term data of Opdivo in treatment-naïve BRAF wild-type advanced melanoma from CheckMate -066. In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The two-year survival and safety data from CheckMate -066 represent the longest follow-up from a randomized study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma. These data will be presented as a late-breaking presentation at the Society for Melanoma Research (SMR) 2015 International Congress in San Francisco, CA from November 18 to 21.”


Checkpoint Inhibitors Show Promise in SCLC, Mesothelioma

“Immune checkpoint inhibitors have demonstrated encouraging results for patients with small cell lung cancer (SCLC) and mesothelioma, two aggressive thoracic malignancies with few options, according to a presentation by M. Catherine Pietanza, MD, at the 10th Annual New York Lung Cancer Symposium.

“ ‘The antibodies to CTLA-4, PD-1, and PD-L1 can be safely given to these patients. Responses are seen and are durable. There is a benefit in both platinum-sensitive and platinum-refractory SCLC,’ said Pietanza, a medical oncologist at Memorial Sloan Kettering Cancer Center.

“Chemotherapy has traditionally been the treatment of choice for most patients with SCLC and mesothelioma beyond the frontline setting. However, outcomes are poor with these therapies, specifically for SCLC, where the median survival following second-line therapy ranges from 6 to 9 months.”


Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for Yervoy (ipilimumab) as Adjuvant Treatment for Fully Resected Stage III Melanoma

Bristol-Myers Squibb Company BMY, -0.27% today announced that the U.S. Food and Drug Administration (FDA) has approved Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy. This approval is based on clinical data from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), which demonstrated Yervoy 10 mg/kg significantly improved recurrence-free survival (RFS) vs. placebo in this setting, with a 25 percent reduction in the risk of recurrence or death. The median RFS was 26 months (95% ci:19)(95% ci:39) for Yervoy vs. 17 months (95% ci:13)(95% ci:22) for placebo (hazard ratio [HR]=0.75; 95% CI: 0.64, 0.90; p<0.002). Yervoy is the first and only FDA-approved immune checkpoint inhibitor in the adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm).”


OK for Flu Shot With Nivolumab, Other Checkpoint Inhibitors?

“The cancer treatment strategy of immune checkpoint blockade has produced unprecedented results in melanoma and lung cancer, as well as in experimental settings with other tumor types, including renal cell carcinoma and mesothelioma.

“Clinicians are not alone in taking notice, according to Niesha Griffith, MS, RPh, a pharmacist at the James Cancer Hospital of The Ohio State University in Columbus.

“Multiple patients at her center have requested these drugs for off-label use, and offered to pay upfront and out-of-pocket for the expensive therapies, she said. Such offers were rare before the advent of cancer immunotherapy, but now occur regularly.”


Nivolumab Improves the Proportion of Lung Cancer Patients Alive After More than a Year

“Patients with a type of lung cancer called non-squamous non-small cell lung cancer (non-SQ NSCLC) have limited treatment options and a dismal prognosis once their disease has advanced and initial treatment with platinum-based chemotherapy has failed. Second-line treatment is usually with another chemotherapy drug, such as docetaxel or pemetrexed.

“Recent results have shown that the drug, nivolumab, improves survival for these and now updated results from the CheckMate 057 phase III clinical trial, to be reported at the 2015 European Cancer Congress today (Monday) with simultaneous publication of the study results in the New England Journal of Medicine, show that nivolumab continues to show an overall survival benefit compared to . Among patients randomised to receive nivolumab, significantly more were alive at 12 months compared to those treated with docetaxel – 51% versus 39% respectively – and a difference in survival remains at 18 months – 39% for nivolumab versus 23% for docetaxel.

“This improvement in survival was observed for all patients included in the trial, but nivolumab was more effective in patients whose tumours expressed a protein called programmed death ligand 1 (PD-L1), which plays a role in the immune system’s ability to recognise and attack tumours and has been correlated with response to immune checkpoint inhibitors such as nivolumab.”


NivoPlus Clinical Trial Currently Recruiting Patients With Advanced Cancer

“The Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center in Arizona recently started a Phase Ib/II clinical trial called NivoPlus (NCT02423954) to test a new investigational immunotherapeutic treatment for several advanced cancers. This novel immunotherapeutic approach is based on the combination of an immunotherapy drug (nivolumab) with chemotherapy drugs (irinotecan, temsirolimus and a combination of irinotecan and capecitabine) which have been approved by the U.S. Food and Drug Administration (FDA).

“Cancer immunotherapy is defined as the use of the body’s own immune system to help fight cancer. In 2013, the renowned Science magazine established that cancer immunotherapy had been the scientific breakthrough of the year, and recent advances in the field have yielded promising results for cancer patients.

“Nivolumab is an antibody against the programmed death 1 (PD-1) receptor, an immune checkpoint that if inhibited results in the stimulation of the body’s antitumor immunity. Nivolumab has been approved by the FDA for the treatment of advanced melanoma in December 2014 and metastatic squamous non-small cell lung cancer in March 2015. Its combination with chemotherapeutic drugs is expected to activate the body’s immune system and improve the response to cancer.”


Melanoma at ASCO 2015: Immunotherapy Continues to Make Headlines


The biggest news in melanoma treatment from the 2015 American Society of Clinical Oncology (ASCO) annual meeting was undoubtedly the report from a large, phase III, randomized clinical trial that compared a combination of two ‘checkpoint inhibitor’ drugs—nivolumab (Opdivo) and ipilimumab (Yervoy)—with the same drugs given alone.

In the CheckMate-067 trial, 945 previously untreated patients with unresectable stage III or IV melanoma were assigned to Opdivo alone, Opdivo plus Yervoy, or Yervoy alone. Continue reading…