Pluvicto pushes earlier in prostate cancer play

From my colleague Allison DeAngelis: Just a couple of months after getting a new approval for its blockbuster prostate cancer drug Pluvicto, Novartis is heading back to regulators with a new package of data that suggest it can be used even earlier in the treatment regimen.

In the midst of ASCO activity yesterday, Novartis reported that a Phase 3 trial of Pluvicto in patients who hadn't yet undergone chemical castration hit its mark, extending progression-free survival. The company didn't release the full data, but plans to do so at a later medical meeting.

Pluvicto sparked interest in the nascent field of radiopharmaceuticals or radioligand therapy, a more precise spin on traditional radiation therapy in which radioactive isotopes are delivered to specific targets.

Over the last couple of years, Novartis has been steadily marching into earlier stages of prostate cancer. In March, the Food and Drug Administration signed off on its use before chemotherapy, a milestone that could help Novartis in its goal to nearly double sales to $5 billion. The data presented at ASCO will also help inch the drug earlier in the treatment spectrum.

The next big test is whether using Pluvicto can delay the advancement of prostate cancer enough to delay chemical castration, which Chief Medical Officer Shreeram Aradhye called "one of the most daunting things that any man diagnosed with prostate cancer faces."

There's also been chatter around the radiopharmaceuticals field around combining these therapies with other types of medicines, like antibody drug conjugates or PARP inhibitors. Aradhye was on the ground at ASCO this past weekend, and said that he was also struck by the number of investigator-initiated combination therapy trials being discussed.

asco

J&J's big bets on bladder, lung, and talent

Also at ASCO, Johnson & Johnson R&D chief John Reed outlined the company's oncology ambitions, spotlighting Rybrevant's $5 billion potential in EGFR-mutated lung cancer and emerging prospects in colorectal cancer, alongside an innovative drug-device combo for bladder cancer called TAR-200 — which showed an 83.5% complete response rate. But in an interview with STAT's Matthew Herper, he did raise concern about America's talent brain drain:

"We're importing talent, and we need that talent to come in. We don't have enough that we're growing organically in this country, and we should make it easy for them to stay, not kick them out," Reed said. "I was always a big fan of Tom Friedman's book, 'The World is Flat,' where he said when you hand them a diploma, you should hand them their green card to say: 'Please stay. We need you.' So I'm really concerned about workforce development as well, in terms of the current administration decisions."

Read more (about this, and other ASCO day four highlights)

glp-1 drugs

Regeneron's obesity combo preserves muscle, but raises flags

Interim data from Regeneron's COURAGE trial suggest that a combination therapy using semaglutide and two other drugs may have improved the quality of weight loss by preserving lean mass and boosting fat loss. The GLP-1 drug was combined with trevogrumab, an anti-myostatin antibody drug, and in some cases with garetosmab, an anti-activin drug.

Patients taking the triple combo saw up to 81% muscle preservation and 27% more fat loss compared to semaglutide alone — but there was also an increase in adverse events, including two deaths in patients with underlying cardiovascular disease. While Regeneron denies a causal link, the tolerability concerns around the triplet arm could complicate the path forward. Full data from the Phase 2 study are expected later this year.

china

How to unclog the biotech bottleneck

China is outpacing the U.S. in biotech agility, leveraging speed and regulatory efficiency while America's innovation engine stalls under bloated costs and red tape. Drug development here is governed by Eroom's Law — ever-rising costs for diminishing returns — with average ROI sinking below 5%. But it doesn't have to be this way, opine Lumen Bioscience CEO Brian Finrow and Sandeep Patel, a consultant and former BARDA official.

Four simple shifts could spark a U.S. rebound, they say: Fast-tracking low-risk trials, standardizing clinical contracts, embracing decentralized studies, and unlocking FDA-held data to level the AI playing field. America doesn't need to mimic China's heavy hand with its economics — it just needs to cut down on the bureaucracy and let scientists do their jobs.