Pharmacists in Smoking Cessation

Nivolumab approved in Europe for treatment in blood cancer as new data shows
promising results of cancer reduction
Bristol-Myers Squibb has announced that the breakthrough immunotherapy Opdivo®q (nivolumab) has been approved for the
treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer. Specifically, the approval is for patients
whose cancer is progressing (relapsed or refractory) despite autologous stem cell transplantation (ASCT) and treatment with
brentuximab vedotin (BV). The approval comes as new data presented at the American Society for Hematology (ASH) congress
shows that nearly 95% of patients in this setting were still alive at one year. At this advanced stage, Hodgkin lymphoma is a
terminal condition with limited therapy options currently available – the announcement highlights nivolumab as an important new
option for these patients.
The primary endpoint of the study showed that considerable cancer reduction was seen in over two-thirds of patients on
nivolumab (68%, 95% CI: 56%, 78%), measured as objective response rate (ORR). In addition, 8% (95% CI: 3%, 16%) of these patients
saw a complete response (CR), where no recognisable sign of cancer remained.
Nivolumab has an innovative mode of action that works by harnessing the ability of the immune system to fight cancer. In
the CheckMate 205 study, presented at the ASH Annual Meeting in San Diego, USA, 12-month progression-free survival (PFS) was
demonstrated in over half of patients (54.6%, 95% CI: 40.9%, 66.4%) with the median duration of response lasting for over a year
(13.1 months, 95% CI: 8.7, not reached). The safety profile of nivolumab was consistent with previously reported data in this tumour
type. Grade 3/4 drug-related adverse events occurred in 29% of patients, the most common were increased lipase (8%), neutropenia
(5%) and increased aspartate aminotransferase (4%).
Hodgkin lymphoma (HL) is a cancer of the lymphatic system. Generally, lymphoma cells grow in lymph glands (nodes) and this
causes the glands to get bigger or swell. HL can start in any part of your body but the most common place for it to start is the neck,
armpit or chest. The lymphoma cells can sometimes spread to other lymph glands. They can also get into your bloodstream and
spread to other organs, for example in your liver, stomach or bowel. HL incidence rates have increased in Ireland, with 133 people
diagnosed with the cancer in Ireland in 2013. Approximately half of all patients with HL are under 35 years old when diagnosed,
only 16% of all patients with HL are 65 years old or over. The disease is the fourth most common cancer in patients aged 15-34
(after testicular cancer, melanoma and breast cancer).
Nivolumab for the treatment of cHL will now undergo a review by the National Centre for Pharmacoeconomics (NCPE) to
determine a recommendation on the cost effectiveness of reimbursement of the drug by the HSE. Nivolumab is currently licensed
in Europe as a monotherapy under the brand name Opdivo ® q for the treatment of adults with:
n Advanced (unresectable or metastatic) melanoma;
n Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy; and
n Relapsed or refractory cHL after autologous stem cell transplantation and treatment with brentuximab vedotin.
In addition, nivolumab is licensed in combination with ipilimumabq for the treatment of adult patients with advanced
(unresectable or metastatic) melanoma.
Novartis announces AMG 334 significantly reduces monthly migraine days in
second pivotal Phase III episodic migraine study
Novartis has announced positive top-line results from the global Phase III STRIVE study, evaluating the efficacy and safety of the
fully human monoclonal antibody AMG 334 (erenumab) in episodic migraine prevention. Once-monthly subcutaneous AMG 334
was evaluated at 70mg and 140mg doses, with both doses meeting the study’s primary endpoint, demonstrating a statistically
significant reduction from baseline in mean monthly migraine days at six months versus placebo. AMG 334 is specifically designed
to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor that is believed to have a critical role in mediating the
incapacitating pain of migraine.
Patients enrolled in STRIVE were randomised to receive either placebo, or one of two AMG 334 doses, 70mg or 140mg,
subcutaneously, once monthly, for six months. Patients experienced between four and 14 migraine days each month, with an
average of 8.3 migraine days per month at baseline. Over the last three months of the double-blind treatment phase, patients in the
70mg and 140mg AMG 334 treatment arms experienced a statistically significant 3.2-day and 3.7-day reduction from baseline in
mean monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.
The safety profile of AMG 334 was comparable to placebo across both treatment arms over the six-month, double-blind
evaluation. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.
Further analysis of the STRIVE data is ongoing.
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