Roche’s Tecen­triq scoops up a big win in small cell lung can­cer, grab­bing the lead in front­line cas­es

Roche’s Genen­tech has scored a land­mark suc­cess in treat­ing small cell lung can­cer, re­port­ing that its PD-L1 check­point Tecen­triq plus chemo helped pa­tients live longer when they re­ceived the com­bo as a front­line ther­a­py. And the score on IM­pow­er133  should put it in the lead in that sec­tor — for now. 

Falling on the heels of some set­backs, Genen­tech ex­ecs are re­port­ing that their com­bi­na­tion ap­proach of­fered sta­tis­ti­cal­ly sig­nif­i­cant re­sults for both over­all sur­vival as well as pro­gres­sion-free sur­vival. The beat over the con­trol arm was al­so iden­ti­fied at an in­ter­im stage, al­low­ing Roche to ac­cel­er­ate plans to get this in­to the hands of reg­u­la­tors.

The win here is cru­cial for Roche, which is play­ing catch-up with check­point lead­ers Bris­tol-My­ers Squibb and Mer­ck. And not all that ef­fec­tive­ly. The phar­ma gi­ant needs to get out well ahead of the com­pe­ti­tion in key ar­eas if they ex­pect to hold on to their third-ranked po­si­tion in the mar­ket, as As­traZeneca moves ahead with its ad­van­tage in one im­por­tant niche of non-small cell lung can­cer.

San­dra Horn­ing

We won’t see Roche’s da­ta un­til an up­com­ing con­fer­ence, stan­dard op­er­at­ing pro­ce­dure in drug de­vel­op­ment.

Ever­core ISI’s Umer Raf­fat and sev­er­al oth­er an­a­lysts have pegged IM­pow­er133 as one of the most sig­nif­i­cant read­outs in SCLC this year, with Bris­tol-My­ers lin­ing up Check­mate-451, where they are study­ing their I/O-I/O com­bo of Op­di­vo and Yer­voy as a main­te­nance ther­a­py.

Ab­b­Vie, mean­while, re­cent­ly con­ced­ed that their try against SCLC with Ro­va-T was a flop. And Mer­ck al­so has failed to ig­nite much en­thu­si­asm so far with its bas­ket study re­sults for Keynote-158 as a sec­ond-line ther­a­py for SCLC.

Mer­ck, mean­while, is ag­gres­sive­ly mov­ing to chal­lenge Roche here, with piv­otal re­sults be­ing as­sem­bled in Keynote-604 for a com­bi­na­tion of Keytru­da and chemo af­ter surg­ing in­to a dom­i­nant po­si­tion in front­line non-small cell lung can­cer.

Now Mer­ck is in the un­usu­al po­si­tion of be­ing sec­ond. Pa­tients, mean­while, can look for­ward to some progress in a dis­ease that has proved stub­born­ly dif­fi­cult to beat.

“These are the first pos­i­tive Phase III sur­vival re­sults for any im­munother­a­py-based com­bi­na­tion in the ini­tial treat­ment of ex­ten­sive-stage small cell lung can­cer, a par­tic­u­lar­ly dif­fi­cult-to-treat type of dis­ease,” said Roche CMO San­dra Horn­ing.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

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

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

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.