Roche stacks up Tecen­triq nods, fol­low­ing up breast can­cer ap­proval with small cell lung can­cer

Roche is carv­ing it­self a tidy niche with Tecen­triq in can­cer pock­ets that oth­er im­munother­a­pies haven’t yet con­quered. Af­ter scor­ing ap­proval in front­line use for breast can­cer last week, the Swiss drug­mak­er on Tues­day said the check­point in­hibitor has se­cured the FDA nod as a first-line treat­ment for ex­ten­sive-stage small cell lung can­cer (ES-SCLC).

Tecen­triq will be added to chemother­a­py — car­bo­platin and etopo­side — as the first new op­tion in more than two decades for treat­ment-naive pa­tients whose small cell lung can­cer has spread, Roche said, adding that the mon­o­clon­al an­ti­body is the on­ly can­cer im­munother­a­py to win ap­proval in this dif­fi­cult-to-treat cat­e­go­ry of pa­tients.

Lung can­cer — which en­com­pass­es small cell lung can­cer (SCLC) and non-small cell lung can­cer (NSCLC) — caus­es the high­est num­ber of can­cer-re­lat­ed fa­tal­i­ties glob­al­ly, the WHO es­ti­mates. SCLC, some­times called oat cell can­cer, ac­count for 10% to 15% of all lung can­cers, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety.

The Tecen­triq ap­proval was based on the Phase III IM­pow­er133 study, the re­sults of which were pub­lished last Sep­tem­ber. Da­ta showed that Tecen­triq in com­bi­na­tion with chemother­a­py helped peo­ple live sig­nif­i­cant­ly longer com­pared to chemother­a­py alone (me­di­an over­all sur­vival=12.3 vs. 10.3 months, re­spec­tive­ly; p=0.0069), and the Tecen­triq com­bo al­so sig­nif­i­cant­ly re­duced the risk of dis­ease wors­en­ing or death com­pared to chemother­a­py alone (PFS=5.2 ver­sus 4.3 months, re­spec­tive­ly; p=0.017).

In the Unit­ed States, Tecen­triq is al­ready ap­proved as a monother­a­py or a com­bo in oth­er types of lung can­cer pa­tients in­clud­ing the ini­tial (first-line) treat­ment of adults with metasta­t­ic non-squa­mous NSCLC with no EGFR or ALK ge­nom­ic tu­mour aber­ra­tions as well as metasta­t­ic NSCLC pa­tients whose dis­ease has pro­gressed dur­ing or fol­low­ing plat­inum-con­tain­ing chemother­a­py.

Roche’s Tecen­triq still has much to do be­fore it catch­es up with de fac­to lead­ers: Mer­ck’s $MRK Keytru­da and Bris­tol-My­ers’ $BMY Op­di­vo, but its strat­e­gy of nab­bing in­di­ca­tions over­looked or ahead of the oth­ers could help es­tab­lish it as a key play­er in the in­creas­ing­ly crowd­ed field.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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