Bris­tol-My­ers con­cedes a PhI­II lung can­cer flop for Op­di­vo as com­pe­ti­tion heats up in SCLC

Bris­tol-My­ers Squibb $BMY has run in­to an­oth­er dead end in ex­plor­ing the lung can­cer mar­ket. 

The big biotech re­port­ed that its Phase III study of Op­di­vo failed the Check­Mate-331 study, un­able to beat the stan­dard of care for treat­ing sec­ond-line small cell lung can­cer.

We don’t know yet just what the da­ta are, just that the read­out doesn’t mea­sure up to a win. And the set­back comes just months af­ter Roche’s com­bo us­ing Tecen­triq and chemo won out on first-line cas­es of SCLC, a tough field that ac­counts for about 15% of the over­all lung can­cer mar­ket.

Ever­core ISI’s Umer Raf­fat and sev­er­al oth­er an­a­lysts have pegged Roche’s IM­pow­er133 as one of the most sig­nif­i­cant read­outs in SCLC this year, with Bris­tol-My­ers lin­ing up an­oth­er try with 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.

To­day, Raf­fat sized up the re­sults as a headache for Bris­tol-My­ers, which is OK’d to mar­ket in this area.

Op­di­vo is al­ready ap­proved in re­lapsed SCLC based on small­er tri­als and CKM-331 was in­tend­ed to be con­fir­ma­to­ry.  There is no deny­ing that this is a dis­ap­point­ing out­come.

Bris­tol-My­ers had jumped out to an ear­ly lead on non-small cell lung can­cer, but was re­cent­ly over­tak­en by an ag­gres­sive bunch of de­vel­op­ers at Mer­ck, who have been hus­tling Keytru­da along with a se­ries of suc­cess­es in piv­otal tri­als. As­traZeneca has al­so en­joyed some im­por­tant niche suc­cess­es in lung can­cer, while Roche has earned the lead spot in SCLC.

At this stage of the great check­point game, we now have 6 ap­proved PD-1/L1 drugs on the mar­ket, with scores more crowd­ing the pipeline be­hind them. The ear­ly suc­cess­es have been key to spawn­ing a multi­bil­lion-dol­lar mar­ket, which has in­spired hun­dreds of com­bi­na­tion and mono ther­a­py tri­als in search of a mar­ket slice in on­col­o­gy.

“Small cell lung can­cer is a high­ly ag­gres­sive dis­ease in which sig­nif­i­cant un­met need re­mains,” said Bris­tol-My­ers’ Sabine Maier in a state­ment. “We are fo­cused on re­search­ing in­no­v­a­tive on­col­o­gy ther­a­pies to im­prove out­comes for pa­tients with lung can­cer. We thank the pa­tients, their fam­i­lies, and the physi­cians in­volved in the Check­Mate -331 study.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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David Zaccardelli, Verona Pharma CEO

Verona’s COPD drug shines in PhI­II study, po­ten­tial­ly clear­ing path to FDA — shares jump

UK-based Verona Pharma’s COPD drug, ensifentrine, has succeeded in its Phase III trial, paving the way for a possible FDA approval.

In Verona’s Phase III ENHANCE-2 study, roughly 800 patients with moderate to severe COPD received ensifentrine or placebo through a nebulizer twice a day for 24 weeks. At 12 hours post-treatment on week 12, the placebo-corrected change in forced expiratory volume (FEV1) — a standard measure of lung function that tests how much breath one can forcefully exhale in one second — was 94 mL, leading the trial to meet its primary endpoint.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

BeiGene touts pos­i­tive PhI­II da­ta on tislelizum­ab in af­ter­math of set­backs at FDA

After the FDA indefinitely delayed its decision on BeiGene’s Novartis-partnered PD-1 drug candidate tislelizumab as a monotherapy for esophageal cancer, Novartis announced that it was scrapping a second application for non-small cell lung cancer. However, BeiGene is holding out hope that there’s yet another way to expand the drug’s market outside of China.

BeiGene put out word Tuesday morning that a Phase III open-label global study, named RATIONALE 301, met its primary endpoint of non-inferior overall survival (OS) versus sorafenib as a first-line treatment in adults with unresectable hepatocellular carcinoma (HCC). The company claimed that the trial, which enrolled more than 600 patients from the US, Europe and Asia, showed a consistent safety profile from previous studies involving tislelizumab and reported no new safety signals.

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