Bristol Myers Squibb (BMS) has announced that its dual immunotherapy combination has been approved by the US Food and Drug Administration (FDA) as a first-line treatment for colorectal cancer (CRC).
Opdivo (nivolumab) plus Yervoy (ipilimumab) is now approved by the regulator to treat adult and paediatric patients aged 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) CRC.
More than 154,000 cases of CRC, which develops in the colon or the rectum, are expected to be diagnosed in the US this year.
Up to 7% of patients with metastatic disease have dMMR or MSI-H tumours and, as a result, are less likely to benefit from conventional chemotherapy and typically face a poor prognosis.
The FDA has already approved Opdivo as a single agent, or in combination with Yervoy, under its accelerated approvals pathway to treat patients aged 12 years and older with MSI-H/dMMR CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
The regulator’s latest decision, which comes over two months ahead of schedule, expands the indication for Opdivo plus Yervoy into the first-line setting and converts the second-line indication to full approval for Opdivo monotherapy.
The new authorisation was supported by positive results from the phase 3 CheckMate-8HW trial, which compared Opdivo plus Yervoy against Opdivo monotherapy in the all-lines setting and against investigator’s choice chemotherapy in the first-line setting.
BMS’ combination reduced the risk of cancer progression or death by 79% compared to chemotherapy in first-line patients. Median progression-free survival (PFS) was not reached in the Opdivo/Yervoy arm versus 5.8 months in the chemotherapy cohort, and PFS rates were numerically higher with Opdivo plus Yervoy versus chemotherapy at 12- and 24-months.
When compared to Opdivo monotherapy in immunotherapy-naïve patients across all lines of therapy, Opdivo plus Yervoy demonstrated a 38% reduction in the risk of disease progression or death. Median PFS was not reached with Opdivo plus Yervoy and was 39.3 months with Opdivo monotherapy.
Wendy Short Bartie, senior vice president of oncology commercialisation at BMS, said: “People with MSI-H/dMMR metastatic CRC face high unmet need, and Opdivo plus Yervoy is an important new approach in the first-line setting. This milestone can offer hope…”