Roche scores its first PD-L1 win in Chi­na, go­ing straight for SCLC niche

Just weeks af­ter As­traZeneca’s Imfinzi be­came the first and on­ly ap­proved PD-L1 drug in Chi­na, reg­u­la­tors have ush­ered in Roche’s Tecen­triq to the check­point fren­zy.

Hong Zhou

The Swiss phar­ma gi­ant is go­ing straight for a niche that it knows well: ex­ten­sive-stage small cell lung can­cer. Per its es­ti­mates, two thirds of SCLC pa­tients have reached this phase by the time they are di­ag­nosed, lead­ing to a poor prog­no­sis and an av­er­age 5-year sur­vival rate of 2% de­spite the use of chemo.

As with the US OK, Chi­na’s Na­tion­al Med­ical Prod­ucts As­so­ci­a­tion based its ap­proval on the Phase III IM­pow­er133 study, which showed that Tecen­triq in com­bi­na­tion with chemother­a­py helped peo­ple live sig­nif­i­cant­ly longer com­pared to chemother­a­py alone (me­di­an over­all sur­vival 12.3 months vs 10.3 months; p=0.0069). The Tecen­triq com­bo al­so re­duced the risk of the dis­ease wors­en­ing, with pro­gres­sion-free sur­vival reach­ing 5.2 months com­pared to 4.3 months on chemo alone (p=0.017).

Thanks to re­forms in­sti­tut­ed in 2017, these da­ta col­lect­ed from glob­al stud­ies went on to sup­port Chi­na ap­proval.

“In March 2019, the US FDA ap­proved Tecen­triq for the small cell lung can­cer in­di­ca­tion,” Hong Zhou, Roche’s Chi­na gen­er­al man­ag­er, said in a state­ment post­ed on WeChat. “In less than a year’s time, Tecen­triq was ap­proved in Chi­na for small cell lung can­cer. It is an­oth­er tes­ta­ment to the res­o­lu­tion as well as re­sults of the Chi­nese gov­ern­ment speed­ing up the re­view of new drugs such that Chi­nese pa­tients can have ac­cess to the lat­est drugs as Eu­ro­peans and Amer­i­cans.”

With PD-1 lead­ers Mer­ck and Bris­tol-My­ers al­ready in the mar­ket, Roche in­di­cat­ed that it would con­tin­ue to pur­sue the niche find­ing strat­e­gy that has suit it well, fo­cus­ing on small­er pa­tient pop­u­la­tion oth­er im­munother­a­pies may not have reached.

The win for Tecen­triq in small cell lung can­cer, it added, means it has full cov­er­age of the lung can­cer land­scape in Chi­na. Tarce­va (an­ti-EGFR), Ale­cen­sa (an­ti-ALK) and Avastin (an­ti-VEGF) are all po­si­tioned for non-small cell lung can­cer.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.