Pfiz­er vs J&J: Re­searchers are duk­ing it out for the cham­pi­onship ti­tle in non­metasta­t­ic prostate can­cer

Pfiz­er $PFE and J&J $JNJ have come down to the wire with piv­otal da­ta on non­metasta­t­ic prostate can­cer. And there are bil­lions of dol­lars in rev­enue on the line here.

Both com­pa­nies post­ed their ab­stracts be­ing re­viewed at AS­CO’s Gen­i­touri­nary Can­cers Sym­po­sium Mon­day evening. And while sci­en­tists frown on com­par­ing da­ta from two dif­fer­ent stud­ies, you can bet that an­a­lysts will be lin­ing up the re­sults side-by-side to see who will come out ahead.

Mace Rothen­berg, Pfiz­er

On the one hand you have Pfiz­er, which post­ed an im­pres­sive 21.9-month im­prove­ment  in metas­ta­sis-free sur­vival for prostate can­cer — 36.6 months vs 14.7 months [P < .0001] — for Xtan­di as well as time to first use of new an­ti­neo­plas­tic ther­a­py (39.6 mo vs 17.7 mo [P < .0001]) and time to PSA pro­gres­sion (37.2 mo vs 3.9 mo).

On the oth­er is J&J, which is fight­ing hard to re­tain patent pro­tec­tion on Zyti­ga, which along with Xtan­di has changed the stan­dard of care in prostate can­cer. Study­ing a next-gen drug dubbed apa­lu­tamide, their piv­otal tri­al hit a me­di­an MFS rate of 40.5 months vs 16.2 months in the place­bo group. “Sec­ondary end­points (TTM, PFS, and Sym­Prog) were all sig­nif­i­cant­ly im­proved.”

That’s a 24.3-month im­prove­ment in MFS, which was 2.4 months bet­ter than its ri­val ther­a­py at Pfiz­er.

But is that big enough to make a siz­able dif­fer­ence?

You can ex­pect to see a lot of com­men­tary on this top­ic in the com­ing days, es­pe­cial­ly with J&J’s Zyti­ga fran­chise hang­ing in the bal­ance in a fed­er­al cour­t­house. But don’t ex­pect Pfiz­er to back away be­cause the ex­per­i­men­tal con­tender got the edge on MFS.

“When we saw this (da­ta)” on Xtan­di, says Mace Rothen­berg, the chief de­vel­op­ment of­fi­cer for Pfiz­er’s on­col­o­gy group, “we were sur­prised and ex­tra­or­di­nar­i­ly pleased. This is not a re­sult in the gray area.”

“Out of my 30 years ex­pe­ri­ence,” adds Rothen­berg, “the haz­ard ra­tio for the pri­ma­ry and sec­ondary end­points are the best I’ve ever had a hand in.”

In­ves­ti­ga­tors have been par­tic­u­lar­ly in­ter­est­ed in pa­tients with rapid­ly ris­ing PSA scores, a high-risk group that may be par­tic­u­lar­ly in need of a ther­a­py like this. There’s al­so been more re­search on the link be­tween metas­ta­sis-free sur­vival and over­all sur­vival, which they’ve been pay­ing rapt at­ten­tion to. And with a trend to­ward a sur­vival ben­e­fit in the study at this stage, Rothen­berg thinks that the OS re­sults will line up nice­ly when the da­ta ma­ture.

Mark Wild­gust, J&J

Of course, J&J thinks ex­act­ly the same thing about apa­lu­tamide.

“The re­sults are in­cred­i­bly com­pelling,” says Mark Wild­gust, vice pres­i­dent of med­ical af­fairs for J&J, who worked on this study with his on­col­o­gy team and gave me a pre­view of the da­ta. Not on­ly is the im­prove­ment in MFS dra­mat­i­cal­ly clear, it’s al­so im­por­tant­ly that pa­tients’ qual­i­ty of life scores demon­strat­ed that the im­prove­ment didn’t come with a sig­nif­i­cant cost of ad­verse events.

Wild­gust al­so cau­tions that J&J will be able to re­veal more about the sec­ondary end­points in their study lat­er this week, which he be­lieves will add to the prod­uct pro­file that they’re build­ing.

J&J shouldn’t have long to wait be­fore the FDA sig­nals whether it is buy­ing in­to the next-gen prostate can­cer ther­a­py, with a PDU­FA date set for April, just two months away.

Eval­u­ate Phar­ma has pegged 2022 sales at $1.6 bil­lion for apa­lu­tamide, flag­ging some of the zeal that an­a­lysts have for this drug.

The phar­ma gi­ant land­ed this drug in their $1 bil­lion ac­qui­si­tion of Aragon close to 5 years ago. And top ex­ecs have backed it up, high­light­ing block­buster ex­pec­ta­tions.

It’s a siz­able mar­ket. Rothen­berg says that there are 20,000 men di­ag­nosed with non-metasta­t­ic prostate can­cer each year in the US.

“We feel very con­fi­dent in the re­sults we’ve gen­er­at­ed and the ex­pe­ri­ence we’ve had,” adds Rothen­berg, who is al­so quick to cau­tion against di­rect com­par­isons like this. All of these stud­ies are like­ly to in­clude sub­tle nu­ances that could af­fect ag­gre­gate out­comes. At the same time, he’s ready to spell out why he thinks Xtan­di is the su­pe­ri­or drug.

Xtan­di “has been on the mar­ket 6 years, 185,000 men have re­ceived Xtan­di, which has es­tab­lished a very strong and large foun­da­tion of ev­i­dence” like­ly to make prac­ti­tion­ers feel com­fort­able about us­ing their drug in this cat­e­go­ry, he says.

It’s in the hands of reg­u­la­tors now, but giv­en the way the FDA has viewed piv­otal da­ta and likes to back new choic­es for prac­ti­tion­ers, both of these drugs look like strong con­tenders for an ap­proval lat­er in the year. And that would leave the two gi­ants con­tin­u­ing to duke it out for mar­ket share — to the ben­e­fit of all the pa­tients fight­ing prostate can­cer.

Ben Davies, an as­so­ciate pro­fes­sor of urol­o­gy at the Uni­ver­si­ty of Pitts­burgh, had this to say on Twit­ter:

Looks like min­i­mal dif­fer­ences. I’ll go with ap­proval for apa­lu­timide. Xtan­di will al­so get a new in­di­ca­tion. Ad­ver­tis­ing dol­lars will win the day? Or deals with PBMs (while they are still here).

Im­age: Shut­ter­stock

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.