MacroGenics HER2 drug scores FDA breast cancer nod with Herceptin-topping data

Stamp with blue ink that says "FDA Approved"
MacroGenics' Margenza has been approved by the FDA to treat third-line HER2-positive breast cancer after showing it could top Roche's Herceptin in the setting. (Olivier Le Moal/Getty Images)

MacroGenics’ oncology med Margenza is launching into the crowded HER2-positive breast cancer field. But the company has one advantage it can tout: The drug topped Roche's mainstay therapy Herceptin in a head-to-head trial.

Margenza, or margetuximab, won FDA approval, in tandem with chemotherapy, to treat metastatic HER2-positive breast cancer after at least two previous rounds of therapy, MacroGenics said Wednesday. 

MacroGenics plans to roll out Margenza, its first commercial product, in March 2021. Though the Maryland biotech won’t disclose the drug’s price tag until then, the sticker will be “on the low end of the range” of prices for other recently launched HER2 metastatic breast cancer therapies, Paul Norris, VP of commercial strategy and planning, said during a conference call Thursday.

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As analysts noted on the call—and MacroGenics management acknowledged—Margenza is going to face a crowded market.

Seagen’s Tukysa scored approval in May for second-line or later treatment alongside Roche’s Herceptin and chemotherapy. There’s AstraZeneca and Daiichi Sankyo’s blockbuster-to-be antibody-drug conjugate Enhertu, which is, like Margenza, cleared for patients who’ve failed on at least two other treatments. And Puma Biotechnology’s Nerlynx got its own third-line go-ahead in February.

But MacroGenics plans to focus its marketing message on the fact that Margenza is the only product to have staved off tumor progression better than Herceptin in a head-to-head trial, Norris said.

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In the phase 3 Sophia study on 536 patients with previously treated HER2-positive metastatic breast cancer, Margenza and chemo cut the risk of disease progression or death by 24% over Herceptin and chemo. Margenza patients lived a median 5.8 months without their disease worsening, versus 4.9 months in the Herceptin group. A final overall survival readout is expected in the second half of 2021.

Plus, Margenza can be paired with any of four chemotherapies: capecitabine, eribulin, gemcitabine and vinorelbine, as it was in the Sophia trial. “The flexibility of the chemotherapy is something that’ll be a value to certain patient types that may be particularly sensitive to the toxicities of other therapies,” Norris said.

To help with its first commercial launch, MacroGenics has tapped contract marketing shop Eversana. During the five-year collaboration, the two will share commercial costs 50-50, while Eversana will provide a range of services including market access, field training, third-party logistics, medical affairs, and data and analytics, among others.

The sales and marketing efforts will focus heavily on digital and virtual engagement, “with a small commercial field team of account directors focused on higher levels of key oncology and pathway organizations to drive access and awareness activities,” Norris said.

“This strategy enables us to execute the launch in a more efficient manner and helps us preserve cash flow versus a more traditional, salesforce-driven, face-to-face promotional effort, which is considerably less cost-effective particularly under the constraints of COVID,” he added.

RELATED: Investors send Bristol Myers' CVR soaring on rekindled hopes for timely CAR-T site inspection

Margenza has been a relatively low-profile drug in the biopharma world. SVB Leerink analyst Johnathan Chang has projected 2026 U.S. sales of just $87 million in the third-line metastatic breast cancer setting.

But the drug recently excited holders of Bristol Myers Squibb's $9-or-nothing contingent value right, after MacroGenics CEO told Evercore ISI that the FDA had completed its pre-approval inspection of a Margenza manufacturing plant.

That inspection rekindled hopes that a once-delayed manufacturing inspection would come in time for Bristol’s CAR-T candidate liso-cel to win FDA approval by year-end. The CVR, granted to Celgene shareholders in that megamerger and publicly traded since then, will only pay out if the CAR-T med wins its OK before Jan. 1.

MacroGenics is also conducting the phase 2/3 Mahogany trial, pairing Margenza with its PD-1 inhibitor retifanlimab or PD-1/LAG-3 bispecific antibody MGD013, plus chemotherapy, in first-line treatment of HER2-positive gastric cancer. The study also uses Herceptin, in tandem with chemo, as the active comparator.