#AS­CO21: No­var­tis keeps build­ing out sur­vival da­ta for Kisqali, hop­ing to add pres­sure on Pfiz­er's Ibrance

As No­var­tis’ Kisqali for breast can­cer trails Pfiz­er’s Ibrance in sales, the Swiss bio­phar­ma con­tin­ues to trot out long-term sur­vival da­ta it hopes will flesh out the drug’s over­all pro­file.

Ahead of #AS­CO21 this week­end, No­var­tis teased out more da­ta for the CDK4/6 in­hibitor for post­menopausal HR-pos­i­tive, HER2-neg­a­tive metasta­t­ic breast can­cer pa­tients. With more than four years of fol­low-up, Kisqali in com­bi­na­tion with As­traZeneca’s Faslodex pro­vid­ed more than a year of ex­tra sur­vival ben­e­fit com­pared to Faslodex alone.

Su­sanne Schaf­fert

“As over­all sur­vival da­ta ma­ture, we’re proud that Kisqali con­tin­ues to dis­tin­guish it­self, of­fer­ing more life for both younger and old­er women liv­ing with metasta­t­ic breast can­cer,” pres­i­dent of on­col­o­gy Su­sanne Schaf­fert said in a state­ment.

The da­ta come from an ex­plorato­ry analy­sis rough­ly 17 months af­ter the last up­date from this spe­cif­ic tri­al, part of a large pro­gram No­var­tis is us­ing to con­tin­ue eval­u­at­ing Kisqali. No­var­tis not­ed that the added 12 months of sur­vival was some­thing the drug is con­tin­u­ing to show over sev­er­al fol­low-ups in this pop­u­la­tion.

At a me­di­an of 56.3 months, the me­di­an over­all sur­vival for the com­bo ther­a­py proved to be 53.7 months, com­pared to 41.5 months in the con­trol arm. In the first-line set­ting, me­di­an OS was not reached for the com­bo, while Faslodex alone re­sult­ed in a me­di­an of 51.8 months, No­var­tis said.

Then, in the sec­ond-line set­ting, the Kisqali com­bi­na­tion again beat out the con­trol, with me­di­an OS fig­ures clock­ing in at 39.7 months to 33.7 months. The need for chemother­a­py was al­so de­layed to at least four years for the com­bo arm, com­pared to 28.8 months among Faslodex pa­tients.

Wednes­day’s re­sults come about six months af­ter No­var­tis re­vealed Kisqali da­ta from a sep­a­rate tri­al in pre­menopausal women, al­so look­ing at HR-pos­i­tive, HER2-neg­a­tive breast can­cer pa­tients. Those da­ta demon­strat­ed a me­di­an of 11 ex­tra months to live over en­docrine ther­a­py alone.

It’s part of a da­ta pack­age No­var­tis says keeps pro­duc­ing un­prece­dent­ed sur­vival re­sults. The phar­ma tout­ed the pre­menopausal re­sults as the longest sur­vival rate of any drug in that in­di­ca­tion, and Wednes­day’s da­ta were de­scribed the same way.

On the whole, No­var­tis is look­ing to con­tin­ue eat­ing in­to the Ibrance pie and moved clos­er to that goal in 2020. Kisqali tal­lied $870 mil­lion in sales last year, good for a 45% in­crease in sales com­pared to 2019. But Ibrance in the same time frame pulled in more than $5 bil­lion in sales, grow­ing at a less stark but still im­pres­sive 9%.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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