Roche turns up the heat on Lil­ly with an­oth­er Gavre­to ap­proval, el­bow­ing its way in­to the thy­roid can­cer space

Roche and Blue­print Med­i­cines are con­tin­u­ing to put pres­sure on ri­vals Eli Lil­ly and Loxo, as their Gavre­to drug picked up a new ap­proval Wednes­day.

The com­pa­nies an­nounced that the FDA has giv­en the thumbs-up for Gavre­to to treat RET-mu­ta­tion and RET-fu­sion pos­i­tive thy­roid can­cers, less than three months af­ter the drug re­ceived its first ap­proval in non-small cell lung can­cer with RET fu­sions. Gavre­to is now set to ful­ly com­pete with Lil­ly’s Retev­mo af­ter the lat­ter’s brief pe­ri­od as the on­ly de­vel­op­er with an OK’ed med­i­cine for this spe­cif­ic gene al­ter­ation.

Though Roche and Blue­print fin­ished sec­ond to Lil­ly in this race, it was on­ly by a cou­ple of months. Retev­mo picked up its ap­provals all at once back in May and is still in the ear­ly stages of roll­out, net­ting rough­ly $12 mil­lion for Lil­ly in the third quar­ter this year.

Gavre­to’s new ac­cel­er­at­ed ap­proval comes from a Phase I/II study that showed an over­all re­sponse rate of 60% in 55 RET-mu­tant pa­tients with pre­vi­ous treat­ments, and an ORR of 66% in 29 RET-mu­tant pa­tients who were treat­ment-naïve. Ad­di­tion­al­ly, 8 of 9 in­di­vid­u­als with RET-fu­sion pos­i­tive tu­mors demon­strat­ed a clin­i­cal re­sponse to the drug.

In all three pa­tient pop­u­la­tions, the me­di­an du­ra­tion of re­sponse was not reached. Across all tu­mor types, the most com­mon side ef­fects were con­sti­pa­tion, hy­per­ten­sion, fa­tigue, mus­cle pain and di­ar­rhea.

Wednes­day’s ap­proval should ser­vice a much larg­er swathe of thy­roid can­cer pa­tients than in NSCLC, as about 10 to 20% of peo­ple with pap­il­lary thy­roid can­cer have RET fu­sion-pos­i­tive tu­mors and rough­ly 90% of peo­ple with ad­vanced MTC (a rare form of thy­roid can­cer) car­ry RET mu­ta­tions. That con­trasts with RET fu­sions mak­ing up on­ly about 1% to 2% of NSCLC pa­tients.

An­a­lysts now view this race as neck and neck, with Wed­bush’s David Nieren­garten say­ing Gavre­to should split the RET-al­tered thy­roid can­cer mar­ket 50/50 with Retev­mo. Cowen’s Marc Frahm ex­pects a slight­ly small­er mar­ket share for Gavre­to at 35%, not­ing that the drug’s 9% dis­con­tin­u­a­tion rate in thy­roid can­cer re­mained high­er than Retev­mo’s 5%.

Nonethe­less, Frahm projects peak Gavre­to sales to hit about $550 mil­lion per year.

Both phar­ma com­pa­nies have pinned high ex­pec­ta­tions for their re­spec­tive drugs. Roche plunked down $775 mil­lion up­front for the rights in Ju­ly — $675 mil­lion of which was in cash — and promised Blue­print as much as $927 mil­lion in mile­stone pay­ments, in ad­di­tion to roy­al­ties on sales out­side the US. Lil­ly, mean­while, bought out Loxo en­tire­ly for a 68% pre­mi­um price of $8 bil­lion in ear­ly 2019.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.

Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.