#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%.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.