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.

CEO Scott Koenig

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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.