Mer­ck, In­cyte map a Phase III pipeline of their own for a front­line com­bo of Keytru­da and epaca­do­stat

Keytru­da (pem­brolizum­ab)

Last fall In­cyte and Mer­ck whipped up con­sid­er­able en­thu­si­asm for a match-up of their IDO1 en­zyme in­hibitor and Keytru­da in an ear­ly-stage study of melanoma. They fol­lowed up with a com­mit­ment to ex­pand their part­ner­ship to go af­ter a range of can­cers. And this morn­ing the part­ners out­lined ag­gres­sive plans to take the com­bo through sev­en piv­otal tri­als.

Re­searchers for these two com­pa­nies got ex­cit­ed about the po­ten­tial for this com­bi­na­tion af­ter see­ing pro­gres­sion-free sur­vival rates of 74 per­cent and 57 per­cent at 6 months and 12 months among the ad­vanced melanoma pa­tients they treat­ed last year in a Phase I. Their melanoma part­ner­ship was ex­pand­ed to in­clude a Phase III melanoma tri­al. Now they are push­ing ahead in the clin­ic to see if In­cyte’s epaca­do­stat and Keytru­da can make a sig­nif­i­cant dif­fer­ence in front­line use against non-small cell lung can­cer, blad­der can­cer, re­nal can­cer and squa­mous cell car­ci­no­ma of the head and neck (SC­CHN).

Al­ready in a Phase III melanoma study, in­ves­ti­ga­tors are adding:

• Two Phase III stud­ies in first-line NSCLC, in­clud­ing both PD-L1 high-ex­press­ing and PD-L1 un­s­e­lect­ed pop­u­la­tions.
• Two Phase III stud­ies in blad­der can­cer, in­clud­ing one in first-line blad­der can­cer and one in sec­ond-line blad­der can­cer.
• A Phase III study in first-line RCC.
• And a Phase III study in first-line SC­CHN.

Mer­ck is man­ag­ing the tri­al work while the two com­pa­nies share ex­pens­es.

When RBC’s Simos Sime­oni­dis saw the first cut of the Phase I da­ta, he con­clud­ed that In­cyte and Mer­ck have an ex­cel­lent shot of beat­ing out Bris­tol-My­ers Squibb’s piv­otal com­bi­na­tion study of Yer­voy and Op­di­vo for first-line use in non-small cell lung can­cer. And right now, Mer­ck’s abil­i­ty to ma­neu­ver past Bris­tol-My­ers and seize the lead on NSCLC con­tin­ues to stag­ger an­a­lysts.

Mer­ck, of course, is spar­ing no ex­pense in push­ing dozens of piv­otal stud­ies of Keytru­da, in­tent on cap­i­tal­iz­ing on a ma­jor mar­ket op­por­tu­ni­ty and un­will­ing to let a grow­ing field of com­peti­tors ham­per its pur­suit of block­buster rev­enue.

Most re­cent­ly Pfiz­er and Mer­ck KGaA gained an ap­proval for the fourth check­point ther­a­py — com­ing in right be­hind Roche — which un­leash­es an im­mune sys­tem at­tack on can­cer cells. As­traZeneca, mean­while, re­jigged its de­vel­op­ment ef­fort to amp up its work on a com­bi­na­tion of dur­val­um­ab and treme­li­mum­ab.

Ri­vals in the field are pay­ing rapt at­ten­tion to every new move.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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