SANTA CLARA, Calif.—Agilent Technologies Inc. announced this September that the U.S. Food and Drug Administration (FDA) has approved the cancer diagnostic known as PD-L1 IHC 28-8 pharmDx for use in cases of urothelial carcinoma (UC) and of squamous cell carcinoma of the head and neck (SCCHN).
The PDL1 IHC 28-8 pharmDx test enables physicians in the United States to identify which patients with locally advanced or metastatic UC and recurrent or metastatic SCCHN who have disease progression on or after platinum-based chemotherapy would most likely benefit from treatment with Opdivo (nivolumab). Opdivo is an immunotherapy developed by Bristol-Myers Squibb (BMS) and approved in these indications, regardless of PD-L1 status. While the test is not required for treatment, with these latest indications, U.S. pathologists now have access to a clinically validated complementary test to determine tumor PD-L1 status in patients with these difficult-to-treat diseases.
Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90 percent of diagnoses. Data from a recent clinical study, CHECKMATE-275 (funded by BMS), showed that tumor PD-L1 expression assessed by PD-L1 IHC 28-8 pharmDx may help inform which UC patients are more likely to respond to Opdivo.
In the CHECKMATE study published in The Lancet in January of 2017, entitled “Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, Phase 2 trial,” the authors noted: “We assessed nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for safety and activity in patients with metastatic or surgically unresectable urothelial carcinoma whose disease progressed or recurred despite previous treatment with at least one platinum-based chemotherapy regimen. The primary endpoint was overall objective response confirmed by blinded independent review committee in all treated patients and by tumor PD-L1 expression (≥5 percent and ≥1 percent). Nivolumab monotherapy provided meaningful clinical benefit, irrespective of PD-L1 expression, and was associated with an acceptable safety profile in previously treated patients with metastatic or surgically unresectable urothelial carcinoma.”
SCCHN is the most common form of head and neck cancer. Data from a pre-specified exploratory analysis of the CHECKMATE-141 clinical trial showed that tumor PD-L1 expression, as detected by PD-L1 IHC 28-8 pharmDx in SCCHN, may be associated with an enhanced survival benefit for the patient from the use of Opdivo.
The test has previously been approved for melanoma as well as non-squamous, non-small cell lung cancer. PD-L1 IHC 28-8 pharmDx, developed in collaboration with BMS, has a broad utility, reportedly with more clinically validated tumor indications than any other commercially produced PD-L1 assay currently on the U.S. market.
“Immuno-oncology is an important area within cancer treatment, and we are excited about Agilent’s involvement in these advancements and the potential PD-L1 IHC 28-8 pharmDx has in helping to provide information to oncologists considering Opdivo for patients with non-squamous non-small cell lung cancer,” said Jacob Thaysen, president of Agilent’s Diagnostics and Genomics Group, in an October 2015 Agilent news release.
Dako announced the FDA’s approval of the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients with melanoma, writing in a January 2016 Agilent press release: “The PD-L1 IHC 28-8 pharmDx test has now been expanded to include melanoma and may be used by physicians to determine PD-L1 status. Positive PD-L1 status in melanoma has been correlated with the magnitude of treatment effect on progression-free survival from Opdivo (nivolumab), from BMS. These complementary tests are distinct from companion diagnostics, which are essential for safe and effective use of a drug. Biomarker testing is not required for the Opdivo + Yervoy Regimen or Opdivo as a single-agent, but it may provide additional information for physicians regarding the use of Opdivo.”
Agilent partners with pharmaceutical companies to develop diagnostics using both immunohistochemical and genomic-based technologies for cancer therapy. In 2012, Agilent acquired Dako, a well-known provider of reagents, instruments, software and expertise to make accurate diagnoses and determine the most effective treatment for cancer patients. Dako partners with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.
“I am delighted that this approval by the FDA enables our products to help inform better patient selection for these very distressing cancers,” said Thaysen, regarding the recent additions of UC and SCCHN. “Agilent’s Dako brand of innovative pathology diagnostics seek to deliver results that pathologists can trust. Our rigorous design process ensures that evidence is based not only on analytical validation but also clinical validation by inclusion in our partner’s clinical trials.”