Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

Af­ter a busy week­end at #ES­MO21, which in­clud­ed a big read­out for its KRAS drug ada­gra­sib in colon can­cer, Mi­rati Ther­a­peu­tics is ready to keep the pres­sure on com­peti­tor Am­gen with lung can­cer da­ta that will un­der­gird an up­com­ing fil­ing.

In topline re­sults from a Phase II co­hort of its KRYS­TAL-1 study, ada­gra­sib post­ed a re­sponse rate of 43% in sec­ond-line-or-lat­er pa­tients with metasta­t­ic non-small cell lung can­cer con­tain­ing a KRAS-G12C mu­ta­tion, Mi­rati said Mon­day.

It’s the lat­est up­date from the KRYS­TAL study, which is test­ing ada­gra­sib as a monother­a­py and in com­bi­na­tions across mul­ti­ple sol­id tu­mor types. Da­ta from the Phase I por­tion of that study in NSCLC piqued in­vestors’ in­ter­est, with a 45% re­sponse rate that ap­peared to ri­val reg­is­tra­tional da­ta for Am­gen’s so­tora­sib — now ap­proved and mar­ket­ed as Lumakras — in the same in­di­ca­tion.

Now, the Phase II monother­a­py da­ta, which Mi­rati is call­ing “po­ten­tial­ly reg­is­tra­tion-en­abling,” back up those ear­ly re­sults and ap­pear good enough to put ada­gra­sib on the path to ap­proval and in­to a head-to-head com­pe­ti­tion with so­tora­sib. Mi­rati plans to file its NDA for the drug in the fourth quar­ter, the biotech said in a re­lease.

But full re­sults from this co­hort, in­clud­ing com­plete and par­tial re­spons­es and safe­ty da­ta, will have to wait for a med­ical meet­ing ear­ly next year, Mi­rati said. Ada­gra­sib post­ed an 80% dis­ease con­trol rate on June 15 with 98.3% of pa­tients pre­vi­ous­ly treat­ed with im­munother­a­py and chemo.

It’s been a busy week­end at #ES­MO21 for Mi­rati and its clos­est com­peti­tor with com­pet­ing da­ta re­leas­es in col­orec­tal can­cer, which is ex­pect­ed to be the next bat­tle­ground for both drugs. On Sun­day, Mi­rati re­leased da­ta from the Phase II por­tion of KRYS­TAL show­ing so­lo ada­gra­sib post­ed a re­sponse rate of 22% in colon can­cer pa­tients with at least two pri­or lines of ther­a­py, per in­ves­ti­ga­tors, with one un­con­firmed par­tial re­sponse re­port­ed.

The drug post­ed a dis­ease con­trol rate of 87% at a me­di­an 8.9-month fol­low up, with a me­di­an du­ra­tion of re­sponse of 4.2 months and me­di­an pro­gres­sion free sur­vival of 5.6 months.

Mean­while, an ada­gra­sib-ce­tux­imab com­bo post­ed a re­sponse rate of 43% in 28 evalu­able pa­tients with two un­con­firmed par­tial re­spons­es and a dis­ease con­trol rate of 100% at a me­di­an sev­en-month check-in. Af­ter the da­ta cut­off, one of those par­tial re­spons­es was con­firmed, Mi­rati said, while the oth­er PR had pro­gressed.

On Thurs­day, Am­gen un­veiled Phase Ib/II da­ta show­ing a com­bo of so­tora­sib and EGFR in­hibitor Vectibix post­ed an over­all re­sponse rate of 27% in 26 pa­tients with ad­vanced col­orec­tal can­cer with KRAS-G12C. The 27% over­all re­sponse rate in the ini­tial 26 pa­tients, which in­clud­ed five pa­tients who saw tu­mor growth af­ter treat­ment with so­tora­sib monother­a­py, was a far cry bet­ter than the 7.1% re­sponse rate the drug post­ed so­lo in a Phase I test, lat­er up­dat­ed to 9.3%.

In an un­usu­al email late Sun­day, an Am­gen spokesper­son sent a lengthy state­ment point­ing out the dan­gers of cross-tri­al com­par­isons and tout­ing the drug­mak­er’s planned strat­e­gy to pur­sue so­tora­sib com­bi­na­tions for CRC, in­clud­ing a planned third-line-or-lat­er Phase III study.

But on sheer num­bers alone, Mi­rati at the very least looks like a strong com­peti­tor for Lumakras, which hit the mar­ket in NSCLC first and pro­vid­ed proof of con­cept for KRAS in­hibitors on the whole. More da­ta will cer­tain­ly clar­i­fy dif­fer­ences be­tween the drugs, but Mi­rati ap­pears to like where it cur­rent­ly stands.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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