Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San An­to­nio Breast Can­cer Sym­po­sium is tak­ing place this week, and so far, some of the Big Phar­mas are turn­ing out new tri­al da­ta about some of the biggest drugs in the space.

First off, No­var­tis an­nounced that its drug, Kisqali, showed about a year of pro­gres­sion-free sur­vival in pa­tients with dif­fer­ent types of first-line metasta­t­ic breast can­cer. The CDK 4/6 drug was first ap­proved by the FDA in 2017, set­ting it up in di­rect com­pe­ti­tion against Pfiz­er’s Ibrance.

The Phase II study, study­ing 222 pa­tients with dif­fer­ent forms of HR+/HER2- can­cers, showed that Kisqali plus en­docrine ther­a­py dou­bled me­di­an pro­gres­sion-free sur­vival com­pared with com­bi­na­tion chemother­a­py. The chemother­a­py had a me­di­an pro­gres­sion-free sur­vival at 12.3 months, while Kisqali plus en­docrine ther­a­py showed a 24-month me­di­an. The tri­al al­so re­port­ed a p-val­ue of p=0.0007.

No­var­tis said the rest of the da­ta will come as a late-break­ing oral pre­sen­ta­tion clos­er to the end of the con­fer­ence.

As­traZeneca, Dai­ichi tout up­dat­ed OS da­ta in HER2+ 

Just a few months af­ter As­traZeneca and Dai­ichi Sankyo pre­sent­ed da­ta from the DES­TINY-Breast04 tri­al, beat­ing out chemother­a­py in HER2-low pa­tients to such an ex­tent that Jef­feries an­a­lysts called En­her­tu “the gospel” for breast can­cer pa­tients, the pair is back with more da­ta.

Up­dat­ed re­sults from the DES­TINY-Breast03 tri­al test­ed the an­ti­body-drug con­ju­gate, or ADC, in pa­tients with pre­vi­ous­ly treat­ed HER2-pos­i­tive un­re­sectable and/or metasta­t­ic breast can­cer. The ther­a­py, ap­proved by the FDA ear­li­er this year, showed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival com­pared to T-DM1, an­oth­er an­ti­body-drug con­ju­gate ther­a­py that’s sold by Roche as Kad­cy­la.

More specif­i­cal­ly, the ther­a­py showed a 36% re­duc­tion in risk of death, per a sec­ondary end­point analy­sis that puts a p-val­ue at p=0.0037. Af­ter two years of fol­low up, 77.4% of pa­tients in the En­her­tu arm were es­ti­mat­ed to still be alive — com­pared to just un­der 70% on those treat­ed with T-DM1.

The next-gen drug start­ed at­tract­ing more and more at­ten­tion last year, thanks to a read­out at #ES­MO21 that showed En­her­tu cut the risk of dis­ease pro­gres­sion or death by a whop­ping 72% (p=<0.0001) com­pared with Roche’s ADC Kad­cy­la in sec­ond-line un­re­sectable and/or metasta­t­ic HER2-pos­i­tive breast can­cer pa­tients who had pre­vi­ous­ly un­der­gone treat­ment with a Her­ceptin-chemo com­bo, per in­ter­im da­ta at the time.

Pri­ma­ry re­sults from an­oth­er En­her­tu tri­al, the DES­TINY-Breast02 tri­al, were to be pre­sent­ed to­day at the con­fer­ence, per a state­ment from the duo.

Gilead re­ports im­proved re­sponse, sur­vival in PhI­II Trodelvy analy­sis

Gilead is look­ing to ex­pand its Trop-2 tar­get­ed ADC Trodelvy in­to the HER2 can­cer space, and it’s tout­ing some new da­ta to sup­port that move.

Tak­en from a post-hoc analy­sis of the Phase III TROP­iCS-02 tri­al look­ing at Trodelvy ver­sus a com­para­tor chemother­a­py, da­ta showed that Trodelvy im­proved pro­gres­sion-free sur­vival, over­all sur­vival and ob­jec­tive re­sponse rates in pa­tients com­pared to physi­cian’s choice of chemother­a­py across ex­pres­sion lev­els of the Trop-2 pro­tein. The study was done in pa­tients with HR+/HER2- metasta­t­ic breast can­cer who pro­gressed on en­docrine-based ther­a­pies and at least two chemother­a­pies.

The com­pa­ny said that more de­tails will be pre­sent­ed lat­er at the con­fer­ence.

While Trodelvy is an ap­proved ther­a­py al­ready, it has not been ap­proved in HR+ or HER2- metasta­t­ic breast can­cer yet. How­ev­er, the FDA ac­cept­ed an sBLA ear­li­er this year un­der Pri­or­i­ty Re­view — and the PDU­FA date is cur­rent­ly set for some­time in Feb­ru­ary.

Ear­li­er this year, Gilead said at #ES­MO22 that a sec­ond in­ter­im analy­sis of TROP­iCS-02 showed im­proved over­all sur­vival in pa­tients with HR+/HER2- metasta­t­ic breast can­cer in a sta­tis­ti­cal­ly sig­nif­i­cant and “clin­i­cal­ly mean­ing­ful” way. How­ev­er, Jef­feries an­a­lyst Michael Yee point­ed out at the time that based on pre­vi­ous analy­ses, “GILD has al­so stat­ed the OS da­ta are clin­i­cal­ly mean­ing­ful which may im­ply the re­sult is prob­a­bly not be­low 2-3mos based on our in­ter­pre­ta­tion and pri­or dat­a­points.”

Eli Lil­ly re­ports up­dat­ed re­sults from piv­otal Verzenio tri­al

Eli Lil­ly up­dat­ed re­sults from a piv­otal Phase III called monar­chE, test­ing ad­ju­vant Verzenio with en­docrine ther­a­py in pa­tients with HR+, HER2- high risk ear­ly breast can­cer. That da­ta showed an in­crease in both in­va­sive dis­ease-free sur­vival (IDFS), as well as dis­tance re­lapse-free sur­vival (DRFS).

Per the Big Phar­ma, the analy­sis shows a me­di­an fol­low-up pe­ri­od of 3.5 years, not­ing that all pa­tients ei­ther com­plet­ed or dis­con­tin­ued a two-year treat­ment pe­ri­od on the drug.

Lil­ly said that the in­crease in those two met­rics con­tin­ued to get bet­ter at the four-year mark, not­ing 6.4% and 5.9% in IDFS and DRFS, re­spec­tive­ly — and show­ing im­prove­ments from pre­vi­ous­ly-record­ed two and three-year rates in all pre­spec­i­fied sub­groups. The two year rates in the groups was 2.8% and 2.5%.

How­ev­er, the phar­ma did note that OS da­ta “re­main im­ma­ture at this time.”

The monar­chE tri­al, which en­rolled more than 5,600 pa­tients over­all, showed that the risk of de­vel­op­ing “in­va­sive dis­ease” in an ITT pop­u­la­tion was re­duced by just over 33%, with a p-val­ue of p<0.0001. Ad­di­tion­al­ly, Verzenio re­duced the risk of de­vel­op­ing metasta­t­ic dis­ease by 34.1%, al­so with a p-val­ue of p<0.0001.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.