MacroGenics scores first FDA approval with breast cancer med Margenza in third-line patients
In the sustainably hot oncology field, breast cancer has attracted some of the biggest players on the market, including blockbuster meds from Roche and Merck. Now, a new player has taken the field after the FDA gave a thumbs-up to newcomer MacroGenics and its HER2 expressing tumor fighter.
MacroGenics $MGNX scored its first FDA approval Wednesday for Margenza (margetuximab-cmkb) to treat metastatic HER2-positive breast cancer patients who have already received two or more prior HER2 regimens, including at least one in the metastatic setting, the Maryland biotech said.
The pharma was trading up around 5% Thursday morning at roughly $26 per share.
The FDA based its review on data from the Phase III Sophia trial, a head-to-head study pitting a combination of Margenza and chemo to a combo of Roche’s Herceptin and chemo. In that 536-patient study, Margenza posted a 24% reduction in risk of disease progression or death over Herceptin, with a median progression-free survival of 5.8 months on Macrogenics’ drug.
MacroGenics will release pricing information closer to Margenza’s March launch date, executives said on a call with investors Thursday morning. The drugmaker is also awaiting further OSS data for Margenza that is expected to come through in the second half of 2021.
Margenza is hoping to take its place in a suddenly bustling market for later-line breast cancer that includes roughly 7,000 U.S. patients per year. Scoring a head-to-head win against Herceptin, which VP of commercial strategy and planning Paul Norris called the “gold standard” and “a high bar” in comments to investors, as well as showing flexibility with chemotherapy options could help Margenza rise above the fray.
“One of the critical benefits of the study we did is you can combine (Margenza) with different chemotherapies and give the physician higher confidence,” Norris said.
With follow-up OSS data on the way, Macrogenics is looking into its pipeline for a bigger market opportunity for Margenza, including as a first-line therapy for gastric cancer and as a combo regimen with other candidates in the drugmaker’s pipe. The company released data in May showing 43% — 6 of 14 — of patients with advanced HER2 tumors demonstrated an objective response to a combination of margetuximab and MGD013 with 4 confirmed responses and evidence of tumor shrinkage that could drive that response rate even higher.
“We see this as an entry point for the use of this molecule,” CEO Scott Koenig said.
Unlike other drugmakers who build their commercial team in-house, MacroGenics will rely on an an “end-to-end” commercialization deal with Eversana signed in November that will help it rapidly roll out with making a massive investment on its own. The companies will split commercialization rights in the US and Eversana will win a 125% royalty for sales over its licensing fees for the pact.
The partners will wait until March to launch, a delay that MacroGenics portrayed as needed to get the drug’s packaging up to speed. Norris said on the call the company delayed its commercialization plans as discussions with the FDA ramped up.
“We’ve been very focused on making sure we didn’t invest too soon too much,” Norris said. “We waited until we had stronger interactions with the FDA before we started to engage on the other commercialization activities.”
Editor’s Note: This story has been updated to correct an error. Paul Norris, VP of commercial strategy planning, spoke on behalf of MacroGenics on the Thursday investor call.