FDA Approves OPDIVO® for Adjuvant Treatment of Malignant Melanoma

January 14th, 2018

The FDA on December 20, 2017, granted regular approval to the anti-PD1 monoclonal antibody, OPDIVO® (Nivolumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. The approved adjuvant therapies over the past two decades, for patients with high-risk melanoma have included high-dose INTRON® A (Interferon alfa-2b), SYLATRON® (peginterferon alfa-2b), and high-dose YERVOY® (Ipilimumab). The significant toxicities associated with these adjuvant interventions, precluded the wide spread use of adjuvant therapy in high risk melanoma.

OPDIVO® is a less toxic, better tolerated, adjuvant treatment option than YERVOY®, for patients with resected stage IIIB/C and IV melanoma, regardless of BRAF mutation. The Recurrence Free Survival rate at 18 months with OPDIVO® was 66.4% compared with 52.7% for YERVOY® and this meant a 35% reduction in the risk of recurrence or death with the OPDIVO® versus YERVOY®.  This will fulfill the unmet need  for adjuvant therapies, with improved benefit-risk ratio, for this patient group.


KEYTRUDA® – A promising Immunotherapy for Metastatic Melanoma

September 13th, 2014

The FDA granted accelerated approval to KEYTRUDA® (Pembrolizumab), a humanized anti PD-1 antibody, for the treatment of patients with advanced Metastatic Melanoma, who have disease progression following YERVOY® (Ipilimumab) and if BRAF V600 mutation positive, a BRAF inhibitor. KEYTRUDA® produced significant and durable responses in patients with advanced Melanoma, regardless of prior therapy with YERVOY® and this benefit was accomplished with minimal toxicities. This new entry will revolutionize the treatment of advanced Melanoma.


Advanced Melanoma – Bringing Bench Research to the Patient’s Bedside

June 14th, 2013

Lambrolizumab (MK-3475) is a humanized anti–PD-1 monoclonal antibody that has demonstrated significant benefit for those patients with advanced Malignant Melanoma regardless of their prior therapy with anti-CTLA 4 antibody, YERVOY® (Ipilimumab). The programmed death 1 (PD-1) receptor is an inhibitory receptor expressed on activated T-cells in the tumor micro environment. The anti–PD-1 antibody by blocking the PD-1 receptor essentially unleashes the immune system to fight off cancer cells. This information published in the NEJM in June 2013 and presented at the 2013 ASCO annual meeting gives an additional option for patients with advanced Malignant Melanoma.


Improving Survival in Metastatic Melanoma

June 17th, 2011

Approximately 50% of the patients with melanoma have an activating BRAF mutation, V600E.  Vemurafenib is an oral BRAF kinase inhibitor. In a randomized phase III study involving treatment naive patients with unresectable stage III or stage IV melanoma patients with BRAF mutation V600E, Vemurafenib significantly improved progression free survival (PFS) and overall survival (OS) compared to Dacarbazine (DTIC). This is a major advance in the field of personalized medicine and molecular targeted therapy.  This information was presented at the 2011 ASCO meeting.


Aggressive Melanoma in patients with CLL

December 27th, 2010

It appears that patients with a history of Chronic Lymphocytic Leukemia (CLL) are at a higher risk of developing Malignant Melanoma. If they do develop this skin cancer, they tend to have more aggressive disease than their non-CLL counterparts, with a higher mortality rate. This may be related to genetic aberrations common to both CLL and Malignant Melanoma. They include genetic aberrations of P53 gene and proto-oncogene B-Cell Lymphoma- 2 (Bcl-2).

It is therefore important that patients with CLL be closely monitored for melanoma and take the necessary sun-protective measures. Further, even when diagnosed with early stage Malignant Melanoma, these individuals may need aggressive local intervention.


Oncoprescribe Blog: Improving Survival in Advanced Malignant Melanoma

November 1st, 2010

Advanced malignant melanoma has been an elusive disease with very few treatment options. There has been no treatment available to improve survival. That changed in June 2010 following the presentation of results from a landmark study.

Ipilimumab is an antibody that targets an antigen called CTLA-4 (Cytotoxic T- Lymphocyte-associated Antigen 4) present on the surface of T cells. T cells or T lymphocytes play a key role in cell mediated immunity. CTLA-4 which is present on the surface of T cells has a negative effect on T cell activation. By blocking CTLA-4, T cells are activated to attack and kill melanoma cells.

Ipilimumab in a randomized phase III trial doubled the survival rates compared to the control group. Studies are underway combining this agent with BRAF inhibitors. Stay tuned.


Oncoprescribe Blog: Malignant Melanoma – An Elusive Disease?

October 24th, 2010

Not anymore. A point mutation in the BRAF proto-oncogene has now been identified. This is detected in approximately 60% of the patients with metastatic melanoma. This mutation appears to be one of the key genetic drivers responsible of the initiation and progression of malignant melanoma. Several selective BRAF inhibitors are in development and these agents have demonstrated significantly high overall response rates. In addition to the anti-CTLA-4 monoclonal antibodies we may soon have a new player with a different mechanism of action to combat this deadly disease.