Over a year af­ter re­jec­tion, Im­munomedics emerges with po­ten­tial block­buster ap­proval

A tur­bu­lent 16 months for Im­munomedics has end­ed in a po­ten­tial block­buster ap­proval, as the FDA grant­ed an ac­cel­er­at­ed OK for their drug to treat an ag­gres­sive form of breast can­cer.

The drug, brand­ed as Trodelvy, is ap­proved for metasta­t­ic triple neg­a­tive breast can­cer — breast can­cers that lack the onco­genes that tar­get­ed ther­a­pies go af­ter and that have helped make the dis­ease treat­able for some pa­tients. The drug, which had break­through sta­tus and pri­or­i­ty re­view, showed a 33% re­sponse and me­di­an du­ra­tion of re­sponse of 7.7 months in 108 pa­tients en­rolled in their Phase II tri­al. Peak sales es­ti­mates can range as high as around $3 bil­lion.

The ap­proval comes over a month in ad­vance of the com­pa­ny’s June 2 PDU­FA date, con­tin­u­ing the agency’s trend of quick­ly ap­prov­ing can­cer drugs they deem ef­fec­tive.

Be­hzad Ag­haz­adeh

A lit­tle over a year ago, the FDA sur­prised both the com­pa­ny and in­vestors by re­ject­ing the drug. Al­though Im­munomedics $IM­MU said the con­cern had on­ly been with qual­i­ty con­trols over the fa­cil­i­ty where the drug is pro­duced, the re­jec­tion of the biotech’s main as­set shaved $1 bil­lion off the com­pa­ny’s mar­ket cap. Not long af­ter, an FDA in­spec­tion doc­u­ment raised con­cerns of a da­ta breach at one of the com­pa­ny’s fa­cil­i­ties. The CEO and CSO both lat­er ex­it­ed, and chair­man Be­hzad Ag­haz­adeh stepped in to run the com­pa­ny.

The drug, known chem­i­cal­ly as sac­i­tuzum­ab govite­can, is the com­pa­ny’s first ap­proval in their 37-year his­to­ry. An an­ti­body-drug con­ju­gate, it con­sists of a tu­mor-tar­get­ing an­ti­body at­tached to a cell-killing small mol­e­cule. The tu­mor en­gulfs the con­ju­gate and the mol­e­cule kills the can­cer cells. The idea first emerged in the ear­ly 2000s be­fore pe­ter­ing out, but has gained trac­tion again in re­cent years, most no­tably with the re­cent ap­provals of Seat­tle Ge­net­ics’ Ad­cetris and Pad­cev.

Seat­tle Ge­net­ics near­ly ac­quired the Im­munomedics drug in 2016. They agreed to an up-to $2 bil­lion deal worth $300 mil­lion be­fore ven­Bio, which owned a 9.9% stake in the com­pa­ny, led a cam­paign against the deal, with then-man­ag­ing parter Ag­haz­adeh ac­cus­ing the com­pa­ny’s lead­er­ship of try­ing to en­rich them­selves. The hus­band-and-wife team who then ran the com­pa­ny as CSO and CEO re­signed, and Ag­haz­adeh lat­er or­ga­nized a $250 mil­lion roy­al­ty deal to fund the com­pa­ny’s work.

Harout Se­mer­jian

An ac­cel­er­at­ed ap­proval is con­di­tion­al on the com­pa­ny con­duct­ing a fol­low-up study. That tri­al, though, has al­ready been stopped, with an in­de­pen­dent re­view board telling Im­munomedics ear­ly this month their drug had al­ready shown enough com­pelling ef­fi­ca­cy. On the same day of the tri­al news, the com­pa­ny al­so an­nounced that No­var­tis On­col­o­gy vet Harout Se­mer­jian had been named as the new CEO.

Com­mit­tee chair and Fred Hutch re­searcher Julie Gralow called the re­sults of the Phase III tri­al “re­mark­able.” The com­ment led Cowen’s Phil Nadeau to write, “There is lit­tle ques­tion that sac­i­tuzum­ab will soon be­come stan­dard of care in the treat­ment of re­lapsed and re­frac­to­ry mTNBC.”

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Seat­tle Ge­net­ic­s' Astel­las-part­nered ADC nails con­fir­ma­to­ry PhI­II in urothe­lial can­cer

Nine months after Seattle Genetics nabbed an accelerated approval for its Astellas-partnered antibody-drug conjugate Padcev, the partners said the therapy has nailed a confirmatory Phase III, proving its worth in locally advanced or metastatic urothelial cancer.

Padcev, which has widely been tapped as a potential blockbuster, scored improvements in both overall survival and progression-free survival compared to chemotherapy, causing a 30% reduction in risk of death (p = 0.001) and 39% reduction in risk of disease progression or death (p<0.00001).

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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