A 'smart bomb,' a new CAR-T, a 100% response, and FDA's Pazdur on accelerated approval

Here are four highlights from the huge cancer meeting called ASCO:

The cancer drug Enhertu cut the rate of death by a third in a group of women with advanced breast cancer in a new clinical trial, a result that could shift treatment for patients known as “HER2-low.” These women wouldn’t qualify for Herceptin but had enough HER2 to serve as a beacon for Enhertu to drop its chemotherapy payload and hit tumor cells. Matthew Herper explains.
Three companies’ Phase 1 clinical trial results on new CAR-T therapies for multiple myeloma offer promising — if early — advances on the current generation of approved myeloma CAR-T therapies. Angus Chen has more.
Something you rarely hear: All of the patients in a colorectal cancer study testing a drug against a rare genetic signature in their tumors had their cancer shrink, sparing them from radiation, chemotherapy, and disfiguring surgery. Matt tells the story.
Sometimes the FDA’s Richard Pazdur has to be blunt with drugmakers granted accelerated approval on products that later turn out not to help. “Peggy Hamburg, a former FDA commissioner, gave me a phrase that I often use: If you don’t see the light, you will soon feel the heat,” he said at a STAT event.

Catching up to monkeypox

There are now two distinct monkeypox outbreaks underway outside Africa, the CDC says, suggesting that international spread is wider and has been occurring for longer than previously realized. Three of 10 viruses sequenced by the CDC differ from the viruses sequenced by countries involved in the outbreak spreading in and from Europe. While the divergent viruses are clearly linked, they also differ more from one another than do the other viruses, CDC’s Inger Damon told STAT’s Helen Branswell Friday.

In an update yesterday, WHO upped its official numbers (which lag public reports) to 780 lab-confirmed cases from 27 countries in regions where the virus is not endemic. It warned cases may appear "atypical" compared to scientific literature, occur with no link to other cases, and are not more severe in people with controlled HIV.

Building a track record for digital diabetes care

It sounds like a winning idea made for health tech: Combine virtual coaching with medical care to make a difference in type 2 diabetes. But so far the virtual care companies have little rigorous data to prove their cases. Yesterday Virta Health came through with results from a five-year trial that looks promising but carries caveats, as do most studies in the nascent field, STAT’s Katie Palmer reports. People who stuck with the virtual program on average saw meaningful weight loss, lower blood sugar, and less diabetes medication use, with 20% achieving diabetes remission.

But the study, presented at the American Diabetes Association meeting and not yet peer-reviewed, was not randomized and didn’t have a control group throughout. When accounting for study dropouts, Virta’s Amy McKenzie told Katie, that 20% diabetes remission rate falls to 9%. Read more.

Closer look: How Roe’s fate could affect IVF and genetic testing of embryos

(ALAN HANDYSIDE/WELLCOME COLLECTION)

Access to abortion will be impacted immediately if the Supreme Court overturns Roe, triggering more restrictive laws in many states. But the ruling could also constrain reproductive care in other ways, from birth control to miscarriage to IVF. Within IVF, particular concern focuses on preimplantation genetic testing, or PGT, which peers into the DNA of embryos made from IVF to help parents avoid passing on a mutation for a life-threatening condition. Now they can choose a mutation-free embryo to implant in a womb, but who gets to decide after Roe?

Roughly two dozen states expected to ban or severely limit abortion will also define when life begins, meaning in some cases lab-made embryos would have legal protections before they’re transferred. STAT’s Andrew Joseph explores how that complicates IVF, PGT, and the fate of existing embryos.

Federal payments to familes tied to fewer reports of child maltreatment

This study’s first sentence flatly states, “Family poverty is a key risk factor for child maltreatment,” citing national research. The current study in Pediatrics lists potential reasons, from stress to depression to neglect before telling us what makes a difference, thanks to the natural experiment of legislative changes to the timing of payments from two income assistance programs: the Earned Income Tax Credit and the Child Tax Credit. These payments have been linked to better birth weights, lower infant mortality, and better child health.

The researchers now say that when they tracked reports of child maltreatment in the four weeks after payments starting after January 2017, rates of maltreatment decreased by 5% for each additional $1,000 per child in the state in the four weeks after the payments.

At-home stool testing offset 2020 colonoscopy dip

The pandemic’s impact on cancer screening tests was a top concern in 2020, prompting fears of delayed diagnoses and worsened outcomes. In those months of stay-at-home orders and canceled screening, rates fell from 80% to 90%. It will take years to understand the full effects of deferred or missed checks, but a new study zeroes in on changes in screening prevalence for three cancer types.

Screening for breast cancer dipped by 6% and for cervical cancer by 11% between 2018 and 2020, the national survey found, and those decreases were consistently larger among people with lower educational attainment and among Hispanic people. For colorectal cancer, stool testing went up 7%, offsetting colonoscopy, which went down by 16%. At-home stool testing increased the most among people with lower socioeconomic status.

What to read around the web today

A more traditional coronavirus shot is on the way. Some people can’t wait, Washington Post
The missing part of America’s pandemic response, The Atlantic
Roche’s TIGIT troubles escalate, sparking more debate about the closely tracked cancer immunotherapy target, STAT
Lebanon's hospitals are running out of medicine and staff in ongoing economic crisis, NPR
Weight loss from bariatric surgery is associated with a reduced risk of cancer in study, STAT