Put It on the Board, 1/18

Opdivo OK’d for adjuvant treatment of melanoma

The FDA approved in December Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

In the phase three CheckMate -238 trial, Opdivo significantly improved recurrence-free survival versus an active comparator, Yervoy (ipilimumab), in patients with stage IIIB/C or stage IV melanoma after surgery, according to the company. This benefit was observed across important subgroups, including in both BRAF mutant and BRAF wild-type patients.

In the CheckMate -238 trial, Opdivo demonstrated an 18-month recurrence-free survival rate of 66.4 percent (95 percent confidence interval: 61.8 to 70.6) compared with 52.7 percent for Yervoy (95 percent CI: 47.8 to 57.4), with the median RFS not yet reached in either group. Opdivo reduced the risk of disease recurrence by 35 percent versus Yervoy (hazard ratio: 0.65; 95 percent CI: 0.53 to 0.80; P <0.0001).
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Horizon to develop FFPE reference standards

Horizon Discovery Group entered into an agreement last month with Roche Diagnostics to assist in the development of immunohistochemistry assays.

Horizon will develop and provide reference standard material expressing neurotrophic tropomyosin receptor kinase (NTRK) fusion biomarkers. NTRK gene rearrangements have emerged as promising targets for cancer therapy, and a number of novel compounds have been developed against the fusion proteins that arise from these molecular alterations. Their effective application depends on the accurate determination of the genotype of patients, primarily through IHC-based testing.

Horizon’s reference standards will be derived from cell lines generated using the company’s gene editing platform to include knock-ins of NTRK 1, 2, and 3 fusion cDNA (each under the control of multiple promoters), to achieve low to high levels of protein expression in selected cell lines. The cells will be supplied in formalin-fixed, paraffin-embedded format. The project is expected to be completed within 12 months.

This agreement builds on the Horizon-Roche partnership announced in 2016, which consisted of the development, manufacture, and commercialization of cell line derivative materials for use as IHC reference standards in cancer tissue diagnostics, to support the development and validation of IHC assays.

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FDA approves Ortho’s Vitros HIV Combo test

The FDA approved Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Ortho’s Vitros 3600 Immunodiagnostic System.

Vitros HIV Combo, a fourth-generation test, detects HIV-1 and HIV-2 antibodies and p24 antigen.

In comparison studies, assay sensitivity was evaluated on seroconversion panels. The Vitros HIV Combo test showed earlier detection of acute HIV infection in six of 32 seroconversion panels (agreement for 25 of 32 panels) when compared with a leading commercially available fourth-generation Ag/Ab test, according to Ortho Clinical Diagnostics.

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Perjeta approved for adjuvant treatment of HER2+ early breast cancer

The FDA approved in December Genentech’s Perjeta (pertuzumab), in combination with Herceptin and chemotherapy (the Perjeta-based regimen), for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence. The FDA also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node-positive).

The FDA-approved use of the Perjeta-based regimen for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence is based on results of the phase three APHINITY study.

Perjeta is also approved for use in combination with Herceptin and docetaxel in people who have HER2-positive breast cancer that has metastasized and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
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3rd respiratory assay cleared on Panther Fusion

Hologic received 510(k) clearance from the FDA for its Panther Fusion AdV/hMPV/RV assay, a multiplexed assay that runs on the Panther Fusion system.

The new assay detects adenovirus, human metapneumovirus, and rhinovirus. It complements the Panther Fusion Flu A/B/RSV assay and the Panther Fusion Paraflu assay, both of which were cleared last fall.

“Clearance and launch of the new Fusion AdV/hMPV/RV assay completes our initial set of modular assays for respiratory viruses,” said Tom West, president of the diagnostic solutions division at Hologic.

The Panther Fusion assays offer a modular approach to syndromic respiratory testing via the ability to run one, two, or all three assays from a single patient specimen.