As­traZeneca keeps the ball rolling on Dai­ichi-part­nered En­her­tu, pick­ing up 2nd in­di­ca­tion in gas­tric can­cer

As­traZeneca’s big gam­ble on Dai­ichi Sankyo’s an­ti­body-drug con­ju­gate En­her­tu has al­ready paid off with a big ap­proval in breast can­cer more than a year ago. But the part­ners have big plans for their block­buster in the mak­ing, and a new nod in gas­tric can­cer will raise their spir­its even high­er.

The FDA on Fri­day ap­proved En­her­tu to treat lo­cal­ly ad­vanced or metasta­t­ic HER2-pos­i­tive gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma in pa­tients who have pre­vi­ous­ly un­der­gone at least one round of treat­ment with a Her­ceptin-based reg­i­men, As­traZeneca said in a re­lease.

En­her­tu, ini­tial­ly ap­proved in late 2019 as a treat­ment for HER2-pos­i­tive breast can­cer, will now bat­tle ad­vanced gas­tric can­cer, a hard-to-treat dis­ease that comes with a poor prog­no­sis. Rough­ly one in five late-stage gas­tric can­cer pa­tients are di­ag­nosed with tu­mors that ex­press the HER2 gene, As­traZeneca said in a re­lease.

The FDA based its re­view on da­ta from the piv­otal Phase II DES­TINY-gas­tric01 tri­al, with da­ta show­ing En­her­tu sig­nif­i­cant­ly ex­tend­ed pa­tients’ lives over stan­dard-of-care chemo. The tri­al pa­tients had been treat­ed with two pri­or rounds of a Her­ceptin-chemo com­bo.

Pa­tients on En­her­tu saw a 41% rel­a­tive re­duc­tion in risk of death com­pared with pa­tients treat­ed with chemother­a­py with a me­di­an OS of 12.5 months ver­sus 8.4 months in the chemo arm, As­traZeneca said. Pa­tients al­so post­ed an over­all re­sponse rate of 40.5% on En­her­tu ver­sus 11.3% on chemo. In terms of com­plete and par­tial re­sponse, En­her­tu post­ed rates of 7.9% and 32.5%, re­spec­tive­ly, com­pared with 0% and 11.3% for chemo.

On top of that, pa­tients ad­min­is­tered the ADC hit a me­di­an pro­gres­sion-free sur­vival of 5.6 months com­pared with 3.5 months in the chemo arm, and a me­di­an du­ra­tion of re­sponse of 11.3 months ver­sus 3.9 months for chemo.

The FDA gave En­her­tu its pri­or­i­ty re­view tag back in Oc­to­ber on the strength of that da­ta, strength­en­ing a sec­ond front in As­traZeneca and Dai­ichi’s quest to take the ADC in­to a range of HER2 ex­press­ing tu­mors.

With­in the span of a week in May, En­her­tu scored two break­through des­ig­na­tions in both gas­tric can­cer and non-small cell lung can­cer. That growth could spell more than $2 bil­lion in peak sales by con­sen­sus es­ti­mates, al­though Dai­ichi has pre­vi­ous­ly float­ed an in­ter­nal es­ti­mate of up to $4.5 bil­lion in peak sales if En­her­tu reach­es its max­i­mum au­di­ence.

As En­her­tu con­tin­ues to pick up steam, it’s adding more and more re­in­force­ment to As­traZeneca’s de­ci­sion to part­ner up on the ADC back in ear­ly 2019 for $1.35 bil­lion in up­front cash and a to­tal pos­si­ble pay­out of $7 bil­lion. With the most re­cent ap­proval, As­traZeneca will owe Dai­ichi $115 mil­lion in mile­stone pay­ments, the drug­mak­er said.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.