As uter­ine race with Ab­b­Vie heats up, My­ovant eyes FDA ap­proval with tri­al re­sults from prostate can­cer

My­ovant has long had a se­cret weapon in its uter­ine ri­val­ry with Ab­b­Vie: Men.

Lynn Seely My­ovant

While the small Swiss biotech has jock­eyed with the Illi­nois-based gi­ant for a foothold in the en­dometrio­sis and uter­ine fi­broid ther­a­py mar­ket, the com­pa­ny has been de­vel­op­ing the same lead com­pound, re­l­u­golix, for use in one of the most com­mon can­cers for the uterus-less: prostate can­cer. To­day, My­ovant is out with pos­i­tive topline re­sults from its big Phase III tri­al on the go­nadotropin-re­leas­ing hor­mone (GnRH) an­tag­o­nist. They say they’ve reached every pri­ma­ry and sec­ondary end­point with p val­ues less than .0001.

“It works quick­ly,” CEO Lynn Seely told End­points News. “It’s an oral pill and it sup­press­es hor­mone pro­duc­tion and when you stop it, your hor­mones come back and you have the po­ten­tial for im­proved qual­i­ty of life.”

My­ovant’s stock is up 95% pre­mar­ket, from $6.06 to $11.80 per share

The tri­al test­ed a re­l­u­golix arm along­side a stan­dard-of-care, le­upro­lide, arm in their abil­i­ty to sup­press testos­terone in pa­tients with ad­vanced prostate can­cer. Testos­terone fu­els prostate can­cer’s growth. The pri­ma­ry end­point was the per­cent­age of men who reached and main­tained med­ical cas­tra­tion, or less than 50 nanograms of testos­terone per deciliter, over 48 weeks.

Re­l­u­golix achieved that in 96.7% of pa­tients — safe­ly clear­ing the FDA’s stat­ed bench­mark for ap­proval of 90%, Seely said. For Japan­ese and Eu­ro­pean ap­proval, they need­ed to show non-in­fe­ri­or­i­ty and did so, with their le­upro­lide arm show­ing on­ly an 88% re­sponse rate.

The re­sults set up an FDA ap­pli­ca­tion in Q2 of 2020 and Eu­ro­pean and Japan­ese ap­pli­ca­tions short­ly there­after, adding to the com­pa­ny’s im­mi­nent US ap­pli­ca­tion for uter­ine fi­broid ther­a­py.

The un­der­ly­ing mech­a­nism be­hind the two ther­a­pies is es­sen­tial­ly in­versed. Le­upro­lide is a GnRH ag­o­nist and de­sen­si­tizes the re­cep­tor by hit­ting it re­peat­ed­ly. Re­l­u­golix blocks it di­rect­ly.

My­ovant’s pitch cen­ters around the speed at which the drug worked, its pill form — rather than le­upro­lide, which is in­ject­ed every three months — and the ta­per­ing of some side ef­fects, which can be lengthy when it comes to testos­terone sup­pres­sion, in­clud­ing hot flash­es, fa­tigue, loss of mus­cle mass, sex­u­al dys­func­tion and de­pres­sion. Doc­tors have some­times giv­en “drug hol­i­days” to man­age the clin­i­cal ben­e­fit against the costs.

“Low­er­ing the testos­terone is bet­ter for treat­ing prostate can­cer,” Seely said. “But it’s not great for the man.”

The ad­verse event ra­tio for both drugs was around 93%, but Seely not­ed a low­ered rate of ma­jor car­dio­vas­cu­lar events in the re­l­u­golix group, 2.9% com­pared to 6.2%. The biotech al­so said hor­mone lev­els re­turned to nor­mal 90 days af­ter treat­ment in the re­l­u­golix group while some­times re­main­ing re­duced at that point or longer for le­upro­lide pa­tients — al­though they did not an­nounce spe­cif­ic num­bers.

So why isn’t Ab­b­Vie, My­ovant’s uter­ine ri­val, pur­su­ing a prostate treat­ment? Seely’s best guess is that it’s be­cause Ab­b­Vie’s GnRH an­tag­o­nist’s half-life is much short­er than My­ovant’s. Ab­b­Vie re­quires high­er dos­es in their uter­ine treat­ments than My­ovant gives — which would mean even high­er dos­es in the prostate ther­a­pies, she said.

The ques­tion, though, is if le­upro­lide is still large­ly ef­fec­tive and the side ef­fects most­ly the same, will doc­tors pre­scribe a new pill in­stead?

“I think the biggest con­cern is that le­upro­lide … has been in the field for decades,” she said. “Some peo­ple ques­tion if on­col­o­gists and urol­o­gists will change their prac­tice.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.