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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.