A study of six people with these variations, out of 79 patients who were previously
treated with ipilimumab for metastatic melanoma, found a higher likelihood of progression - free survival.
A nivolumab / ipilimumab combination and nivolumab alone significantly improved overall survival (OS)
compared with ipilimumab alone for advanced melanoma patients, according to a new study.
As reported in 2015, the study met its primary endpoint after a median follow up of 2.3 years,
with ipilimumab significantly improving recurrence - free survival.2 The drug was subsequently approved by the US Food and Drug Administration as adjuvant therapy for stage III melanoma.
In the largest analysis of PD - 1 blockade in mucosal melanoma to date, patients treated in clinical studies with either nivolumab monotherapy or nivolumab
combined with ipilimumab were evaluated in a pooled analysis.
«But this opens the possibility of improving clinical outcomes and decreasing serious side effects in treating advanced
melanoma with ipilimumab.»
Hodi designed this investigator - initiated clinical trial to find out if giving sargramostim
along with ipilimumab would have a synergistic effect against the melanoma — like pressing the immune system's accelerator while releasing the brake.
In addition, combining the anti-RANKL
antibody with ipilimumab produced a synergistic effect and helped prolong survival.
To investigate if blocking Aire has a synergistic
effect with ipilimumab in humans, researchers drew from a study of people who have natural genetic variations for the Aire gene that are known to make the Aire protein unstable and therefore short - lived in normal cells.
Dr Butler said: «Our results show that patients benefited from pembrolizumab regardless of whether or not they had been
pre-treated with ipilimumab.»
Patient 1 was a woman aged 65 years with metastatic melanoma admitted to a hospital with atypical chest pain, dyspnea, and fatigue 12 days after initiating combination
therapy with ipilimumab and nivolumab.
Current clinical trials include combination of intrahepatic embolization and a radiosensitizer in patients with uveal melanoma and liver - only metastases, a phase I trial that evaluates a combination therapy of
BCG with ipilimumab in Stage III / IV melanoma, and several landmark international trials including a phase II trial that evaluates combination immunotherapy with nivolumab & ipilimumab.
[76] An evaluation of 71 patients with metastatic mucosal melanoma treated
with ipilimumab through an expanded access program in Italy reported a response rate of 12 % and a disease control rate of 36 % at a median follow - up time of 21.8 months.
On the basis of these promising early results, pembrolizumab was recently granted a «Breakthrough Therapy» designation by the FDA, which means that the drug will benefit from a faster, more expedited review by the FDA, and could be approved for use as early as October, 2014 as a second - line treatment for melanoma patients who fail frontline
treatment with ipilimumab (Yervoy ®).
The new drug combination included Nivolumab, which blocks pD - 1 — a molecule that prevents immune cells recognizing and attacking cancer cells —
with ipilimumab which sensitizes the immune system to cancer cells.
In addition, the relatively lower toxicity of the PD - 1 / PD - L1 agents compared
with ipilimumab intensifies interest in the ongoing trials of their combination with intralesional therapies.
A recent study showed that T - VEC in combination
with ipilimumab resulted in an overall response rate of 50 %, durable response rate of 44 %, and tolerable safety profile in patients with advanced melanoma, said Georgina Long, BSc, PhD, MBBS, of the Melanoma Institute Australia in Sydney.
And again, that is an immunologic drug, and it was approved on the basis of prolonged relapse - free survival — that is, prolonged time to return of the tumor
compared with ipilimumab, which as I mentioned was the standard since 2015.
«Efficacy and safety in key patient subgroups of nivolumab (NIVO) alone or
combined with ipilimumab (IPI) versus IPI alone in treatment - naïve patients with advanced melanoma (MEL)(CheckMate 067).»
The group
treated with both ipilimumab and the immune stimulant, called sargramostim, had a one - year survival rate of 68.9 percent vs. 52.9 percent in the ipilimumab - only group.
There were no serious adverse events related to omaveloxolone and it was well tolerated in combination
with ipilimumab or nivolumab.
But clinicians eventually found that
with ipilimumab, many tumors began shrinking later.
Patients with metastatic melanoma who were treated
with ipilimumab, an immune checkpoint blocker, survived 50 percent longer — a median 17.5 months vs. 12.7 months — if they simultaneously received an immune stimulant, according to a study led by Dana - Farber Cancer Institute scientists.
They studied the effects of this treatment in combination
with ipilimumab, a U.S. Food and Drug Administration - approved immunotherapy.
A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO - 2125 in Combination
with Ipilimumab or Pembrolizumab in Patients with Metastatic Melanoma
In patients with tumor programmed death ligand 1 (PD - L1) expression ≥ 5 %, the 2 - year OS rate was higher in the nivolumab arm (72 %) than the combination (68 %); it was 54 %
with ipilimumab.
The phase III CheckMate 067 trial, which included 945 untreated melanoma patients, found that nivolumab alone and in combination
with ipilimumab significantly improved progression - free survival (PFS) and the overall response rate (ORR) compared with ipilimumab alone.
Nivolumab alone or in combination
with ipilimumab are promising treatment options for patients with mucosal melanoma, according to a new study.
The other big melanoma success story came from a trial of Bristol - Myers Squibb's anti-PD-1 drug, nivolumab, given in combination
with ipilimumab.
This discovery has inspired the development of approaches to target this pathway in patients being treated
with ipilimumab.
At a very early follow - up, nivolumab treatment resulted in a statistically significant 12 - month relapse - free survival rate compared
with ipilimumab.