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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.