The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ES­MO Con­gress has had a ma­jor fo­cus on Big Phar­ma drugs — most no­tably can­di­dates from Mer­ck and As­traZeneca — but there have al­so been up­dates from small­er biotechs with da­ta look­ing to chal­lenge the big-name drug­mak­ers.

To­day, we’re high­light­ing some of the da­ta re­leas­es that flew un­der the radar at #ES­MO21 — whether from ear­ly-stage drugs look­ing to make a mark or old­er stal­warts with in­ter­est­ing fol­low-up da­ta.

Here’s the best of the rest:

Agenus high­lights PD-1/CT­LA-4 da­ta in ad­vanced cer­vi­cal can­cer

Agenus on Sun­day pre­sent­ed fi­nal re­sults from its Phase II C-550 study show­ing a com­bi­na­tion of its bal­stil­imab and za­l­ifre­limab post­ed a re­sponse rate of 26% in pa­tients with sec­ond-line re­cur­rent or metasta­t­ic cer­vi­cal can­cer.

The PD-1/CT­LA-4 com­bo re­port­ed 10 com­plete re­spons­es and 22 par­tial re­spons­es among the study’s mod­i­fied 125-pa­tient pool. Mean­while, the com­bi­na­tion per­formed par­tic­u­lar­ly well in PD-(L)1 pos­i­tive pa­tients, with a 32.8% re­sponse rate among 67 pa­tients, who made up the ma­jor­i­ty of the study’s pop­u­la­tion.

At a six-month check-in, 86.5% of re­spon­ders were still re­spond­ing to treat­ment with com­bo, while at one year that num­ber de­clined to 64.2%. Mean­while the com­bo post­ed a me­di­an over­all sur­vival of 12.8 months at a me­di­an 21-month check-in and a PFS of 2.7 months. For the PD-(L)1 pos­i­tive co­hort, me­di­an OS was 15.7 months.

Agenus called this study group the largest to show ben­e­fit for PD-1/CT­LA-4 block­ade in re­cur­rent or metasta­t­ic cer­vi­cal can­cer, tak­ing a shot right at Bris­tol My­ers Squibb’s com­bo of Op­di­vo and Yer­voy, which turned out da­ta in this pop­u­la­tion back in 2019. In the CHECK­MATE-358 Phase II study, Op­di­vo-Yer­voy post­ed a re­sponse rate of 26.3% among 19 pa­tients with five com­plete and par­tial re­spons­es.

Re­gen­eron’s Lib­tayo looks to match Keytru­da’s com­bo ap­proval in 1L lung can­cer

Re­gen­eron’s Lib­tayo in com­bi­na­tion with chemother­a­py aced its sur­vival end­points as part of the Phase III EM­POW­ER-Lung-3 study in first-line pa­tients with metasta­t­ic non-small cell lung can­cer, with da­ta that look very sim­i­lar to what a Keytru­da-chemo com­bo has al­ready post­ed there.

Lib­tayo-chemo hit a me­di­an OS of 22 months with a me­di­an pro­gres­sion-free sur­vival of 8 months, re­duc­ing the rel­a­tive risk of death by 29% com­pared with a chemo reg­i­men alone. Mean­while, the com­bo post­ed a 43% re­sponse rate com­pared with 23% for chemo and a 16-month du­ra­tion of re­sponse ver­sus sev­en months for chemo.

But Keytru­da has the head­start here, with da­ta from the KEYNOTE-189 study show­ing large­ly the same ef­fi­ca­cy num­bers. The FDA grant­ed the Keytru­da-chemo com­bo an ap­proval here back in Au­gust 2018, adding to its ap­proval as a so­lo agent in the same set­ting.

Seagen, Gen­mab roll out com­bo da­ta for ADC in cer­vi­cal can­cer

Speak­ing of cer­vi­cal can­cer, Seagen and Gen­mab have new da­ta out on their in­ves­ti­ga­tion­al an­ti­body-drug con­ju­gate ti­so­tum­ab ve­dotin (TV) show­ing some strong re­sults in com­bi­na­tion with the chemother­a­py car­bo­platin or Keytru­da across mul­ti­ple lines of ther­a­py for re­cur­rent or metasta­t­ic pa­tients.

Ac­cord­ing to co­hort da­ta from the Phase Ib/II in­no­vaTV 205 study, the TV-car­bo com­bo post­ed a re­sponse rate of 55%, in­clud­ing four com­plete re­spons­es and 14 par­tial re­spons­es, in first-line re­cur­rent or metasta­t­ic cer­vi­cal can­cer pa­tients. At a me­di­an fol­low-up of 7.9 months, the com­bo’s du­ra­tion of re­sponse was 8.3 months with a me­di­an pro­gres­sion-free sur­vival of 9.5 months.

Mean­while, a com­bi­na­tion of TV and Keytru­da in sec­ond- or third-line cer­vi­cal can­cer pa­tients post­ed a 38% re­sponse rate in 34 pa­tients, with two com­plete re­spons­es and 11 par­tial re­spons­es re­port­ed. You’ll re­mem­ber the Phase II KEYNOTE-158 study from a cou­ple years ago post­ed a 17% re­sponse rate for so­lo Keytru­da in pre­vi­ous­ly treat­ed ad­vanced cer­vi­cal can­cer, po­ten­tial­ly point­ing to some ben­e­fit for TV as part of the com­bo.

“As we ad­vance our clin­i­cal de­vel­op­ment pro­gram for ti­so­tum­ab ve­dotin in­to ear­li­er lines of ther­a­py in cer­vi­cal can­cer, we’re en­cour­aged by these in­ter­im re­sults of the com­bi­na­tion co­horts with ti­so­tum­ab ve­dotin,” Seagen CMO Roger Dansey said in a state­ment. “Based on these re­sults from the in­no­vaTV 205 study, we al­so plan to eval­u­ate ti­so­tum­ab ve­dotin fur­ther in var­i­ous com­bi­na­tions in first-line metasta­t­ic or re­cur­rent cer­vi­cal can­cer.”

Mer­ck backs up re­cent Keytru­da ap­proval in TNBC with OS win

A com­bi­na­tion of Keytru­da and chemother­a­py re­duced the risk of death by 27% over chemo alone (p=0.0093) in first-line pa­tients with PD-(L)1 ex­press­ing triple-neg­a­tive breast can­cer, ac­cord­ing to da­ta pre­sent­ed Sun­day.

The com­plete OS re­sults come as a back­stop for the FDA’s ac­cel­er­at­ed nod in this in­di­ca­tion back in No­vem­ber, which was up­grad­ed to a full ap­proval in Ju­ly.

The com­bi­na­tion post­ed a me­di­an OS of 23 months com­pared with 16.1 months for chemo. The agency based its ap­proval on da­ta from the KEYNOTE-355 study, which showed the com­bo re­duced the risk of dis­ease pro­gres­sion or death by 35% with a me­di­an PFS of 9.7 months, against 5.6 months in the chemo arm.

No­var­tis’ Kisqali gets long-await­ed OS read­out in HR+/HER2- breast can­cer

Af­ter wait­ing near­ly five years for the da­ta to ma­ture, No­var­tis can now tout an OS win for its CDK 4/6 in­hibitor in first-line ad­vanced HR+/HER2- breast can­cer, the Swiss drug­mak­er said Sun­day.

At a whop­ping 63.9-month fol­low-up, Kisqali com­bined with the aro­matase in­hibitor letro­zole post­ed a me­di­an OS of 63.9 months com­pared with 51.4 months for letro­zole alone — a more than one-year OS ben­e­fit. No­var­tis is call­ing the OS read­out the longest for a CDK 4/6 and a boon for pa­tients af­ter a very long wait for fi­nal re­sults.

The da­ta come from the MONALEESA-2 tri­al, which was the ba­sis for No­var­tis’ ini­tial ap­proval in this in­di­ca­tion way back in 2017.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

Endpoints Premium

Premium subscription required

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

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 119,800+ biopharma pros reading Endpoints daily — and it's free.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

Endpoints Premium

Premium subscription required

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

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 119,800+ biopharma pros reading Endpoints daily — and it's free.

FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

Endpoints Premium

Premium subscription required

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