Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatm | Page 4
Successes with ipilimumab (CTLA-4 inhibitor),
pembrolizumab (PD-1 inhibitor), and nivolumab (PD-1
inhibitor) have led to their approval by the FDA for
specific cancers (Table 1). Ipilimumab resulted in a 25%
reduction in the relative risk of melanoma recurrence,
compared with placebo.4 Tumor regression was
experienced following treatment with pembrolizumab
by ~24% of patients with unresectable or metastatic
BRAF V600 mutation-positive melanoma experiencing
progression after ipilimumab treatment.5,6 In a similar
MARCH 2011
Ipilimumab (Yervoy®), a CTLA-4 checkpoint inhibitor, was
approved by FDA for treatment of refractory or advanced
metastatic melanoma
SEPTEMBER 2014
Pembrolizumab (Keytruda®), a PD-1 checkpoint inhibitor, granted
accelerated approval for treatment of metastatic or unresectable
melanoma that did not respond to other treatments
DECEMBER 2014
Nivolumab (Opdivo®), a PD-1 checkpoint inhibitor, was approved
for treatment of metastatic or unresectable melanoma
OCTOBER 2015
Nivolumab (Opdivo®) approved use expanded for treatment
of advanced (metastatic) squamous non-small cell lung
cancer (NSCLC) with progression on or after platinum-based
chemotherapy
OCTOBER 2015
Pembrolizumab (Keytruda®) granted accelerated approval for
treatment of advanced, unresponsive, PD-L1-positive NSCLC
OCTOBER 2015
Ipilimumab (Yervoy®) approved as adjuvant therapy with stage III
melanoma, to reduce risk of postoperative recurrence
NOVEMBER 2015
Nivolumab (Opdivo®) approved use expanded for previously
treated metastatic renal cell carcinoma
DECEMBER 2015
Pembrolizumab (Keytruda®) approved use expanded to first-line
treatment of metastatic or unresectable melanoma
Table 1. History of FDA approval of immune checkpoint inhibitors
4
patient group, nivolumab resulted in an objective
response rate (ORR) at 6 months of 32%, overall
survival of 72.9%, and 5.1-month progression free
survival.7,8 Similar durable responses have also been
demonstrated in non-small cell lung cancer (NSCLC)
and renal cell carcinoma.8 The FDA has also approved
the combination of nivolumab and ipilimumab for
patients with BRAF wild-type melanoma, who have
little to gain from the use of BRAF inhibitors like
Zelboraf® (vemurafenib).