Dual Bispecific Regimen Shows Strong Phase III Signal in Earlier-Line Relapsed Myeloma

Bispecific antibodies are moving rapidly from late-line rescue therapy into earlier phases of multiple myeloma care. The latest signal comes from MonumenTAL-6, a Phase III study evaluating Johnson & Johnson’s TECVAYLI® (teclistamab) plus TALVEY® (talquetamab) in patients with relapsed or refractory multiple myeloma who had received one to four prior lines of therapy, including an anti-CD38 antibody and lenalidomide.

According to topline results released by the company, the dual bispecific regimen reduced the risk of disease progression or death by 89% compared with investigator’s choice standard of care, corresponding to a hazard ratio of 0.11. The combination also reduced the risk of death by 62%, with a hazard ratio of 0.38. A second investigational arm, TALVEY plus pomalidomide, also met the primary endpoint, reducing the risk of progression or death by 73%.

A dual-antigen strategy

The clinical rationale is clear. TECVAYLI targets BCMA, a validated plasma cell antigen, while TALVEY targets GPRC5D, another antigen highly expressed on myeloma cells. Combining the two agents could deepen tumor control by engaging T cells against two distinct myeloma-associated targets, potentially reducing the likelihood that disease escapes through antigen loss or heterogeneous target expression.

This dual-antigen approach is particularly relevant in earlier-line relapse, where patients may still have better marrow reserve, less heavily treated immune systems, and more opportunity to achieve durable disease control. It also reflects a broader shift in myeloma treatment: immunotherapy is no longer being reserved only for patients who have exhausted conventional options.

“These findings add to a growing body of Phase III evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey,” said Ajay K. Nooka, MD, MPH, director of the Myeloma Program at Emory University School of Medicine.

Topline data, not yet full clinical detail

MonumenTAL-6 compared TECVAYLI plus TALVEY and TALVEY plus pomalidomide with investigator’s choice of elotuzumab, pomalidomide and dexamethasone or pomalidomide, bortezomib and dexamethasone. The Independent Data Monitoring Committee recommended unblinding the study at the first interim analysis, and Johnson & Johnson said full data will be presented at a future medical meeting and submitted to global regulatory authorities.

That timing matters. The reported hazard ratios are striking, particularly for progression-free survival with the TECVAYLI-TALVEY arm. However, clinicians will need the full dataset to assess response depth, duration, subgroup consistency, treatment discontinuation, infection burden, cytopenias, quality-of-life effects, and practical feasibility in community settings.

Safety will be central to interpretation. Both drugs are T-cell redirecting bispecific antibodies and carry risks including cytokine release syndrome, neurologic toxicity including ICANS, infections, cytopenias, and other target-specific adverse events. The company reported that overall safety profiles in MonumenTAL-6 were consistent with the known profiles of the individual monotherapies, but detailed rates from the combination study have not yet been released.

Implications for myeloma sequencing

If confirmed, these data could strengthen the case for earlier use of off-the-shelf bispecific combinations in relapsed myeloma. TECVAYLI is already approved in combination with daratumumab and hyaluronidase in certain patients after at least one prior line of therapy, while TALVEY is currently approved as monotherapy for more heavily pretreated relapsed or refractory disease.

The key question is no longer only whether bispecific antibodies work, but how they should be sequenced and combined alongside CD38 antibodies, proteasome inhibitors, immunomodulatory drugs, CAR T therapies, and emerging antibody-drug conjugates. A BCMA/GPRC5D combination may offer a way to intensify immune pressure without the manufacturing delays associated with autologous cell therapy, but it will also require careful infection prevention, monitoring infrastructure, and patient selection.

For now, MonumenTAL-6 adds an important signal to the changing treatment landscape. Earlier-line myeloma therapy is becoming increasingly immunotherapy-based, and dual-antigen targeting may become one of the strategies used to push responses deeper and make remission more durable.

The post Dual Bispecific Regimen Shows Strong Phase III Signal in Earlier-Line Relapsed Myeloma appeared first on Inside Precision Medicine.

<![CDATA[Placebo and nocebo effects shape psychiatric care—how expectations and framing boost medication benefit and reduce side effects.]]>
<![CDATA[Don’t miss out on these CME articles! Test your knowledge here.]]>

International OCD Foundation Responds to OCD Representation in TLC’s “90 Day Fiancé”

Recent conversations about the portrayal of OCD on TLC’s 90 Day Fiancé underscore an important truth: how OCD is portrayed in television, film, and other media matters.

OCD is a serious, often debilitating mental health disorder affecting millions of people. It is characterized by unwanted, intrusive thoughts, images, or urges (obsessions) and repetitive behaviors or mental acts (compulsions) performed in an attempt to reduce distress. While OCD can look different from person to person, it is highly treatable. Yet today, nearly 95% of people with OCD are not receiving the most effective treatment. Misunderstanding OCD makes it harder for people to recognize their symptoms, receive an accurate diagnosis, and get the care they need to reclaim their lives.

Each episode of 90 Day Fiancé is watched by more than one million viewers. With that kind of reach comes an extraordinary opportunity to shape public understanding of mental health for the better. Accurate portrayals of OCD have the power to transform lives. They replace myths with understanding, reduce stigma, help people recognize the signs of OCD sooner, inspire individuals to seek effective treatment, and let those living with OCD know they are not alone—and that recovery is possible.

The entertainment industry has a responsibility to get it right, and doing so requires thoughtful decisions at every stage of the creative process. The International OCD Foundation encourages TLC to engage clinical experts and people with lived experience to better inform their editorial decisions. We stand ready to serve as a resource for future portrayals of OCD and related disorders.

If you are creating content that includes OCD or related disorders, we encourage you to connect with us at media@iocdf.org. Together, we can improve public understanding of OCD, reduce stigma, and help more people find the treatment that can change their lives.

The post International OCD Foundation Responds to OCD Representation in TLC’s “90 Day Fiancé” appeared first on International OCD Foundation.

The Download: an organ transplant breakthrough, and homegrown Chinese chips

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

Supercooled kidneys have been transplanted into pigs in a “landmark achievement” 

When it comes to organ donation, time is everything. As soon as an organ has been removed from a donor’s body, it starts to deteriorate. Surgeons have only a matter of hours to get it into a recipient.

In most cases, organs will be kept on ice during that time, at around 4 °C (39 °F). They cannot be frozen—in previous attempts, ice has formed, causing all kinds of damage.

But now, scientists have come up with a device that allows organs to be cooled to -4 °C (25 °F) without forming any ice. They’ve tested it with pig organs and shown that kidneys, at least, can be preserved in the device for days then successfully transplanted. 

Read our story about their breakthrough, and why it raises hopes for longer-term storage of donated human organs.

—Jessica Hamzelou

If you want to read more about this story and its implications for organ preservation and transplantation, sign up to receive The Checkup, our weekly biotech newsletter, later today.

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 Inside China’s epic push to replace US chips 
The gap between their chips’ capabilities remains large—for now. (WSJ $)
How China is using open source AI as a new form of soft power around the globe. (NYT $)
A new bill in the US takes aim at Chinese AI companies’ training practices. (NBC)
US lawmakers are also mulling banning the military from using Chinese humanoid robots. (SCMP)

2 Space data centers don’t exist yet, but people already oppose them
Environmental experts warn it’ll further pollute the stratosphere. (Guardian)
Four things we’d need to put data centers in space. (MIT Technology Review)
What it’s like inside the data centers powering AI down here on Earth. (Axios)
The left and right are finding common cause with data center protests in the US. (The Verge)

3 US lawmakers are pushing for an AI ‘kill switch’
After OpenAI’s models went rogue and hacked Hugging Face. (BBC)

4 Peptides seem on the cusp of going mainstream in the US
A lack of scientific evidence didn’t stop the FDA just voting to let some pharmacies to legally dispense them. (Wired $)
How does Make America Healthy Again hold up to scientific scrutiny? (Nature)
US measles cases are reaching levels not seen for three decades. (Wired $)
Peptides are everywhere. Here’s what you need to know. (MIT Technology Review)

5 The EU just fined Google almost $1 billion
For competition breaches over apps and search. (FT $)
+ It came just a day before Trump renewed tariffs on 60 trading partners, including the EU. (BBC)

6 Electric vehicles are selling well in Europe
And the share made by Chinese firms has doubled in the last year. (The Next Web)
Hybrids are hot property in the US this summer. (Wired $)

7 There’s a worsening shortage of computer science professors
You can blame AI companies—they keep snapping them up, to our general detriment. (The Atlantic $)

8 A judge caught a stenographer allowing AI errors into their transcript 
It’s apparently the first time this has happened, but it certainly won’t be the last. (404 Media)
Even judges themselves are falling for AI. (MIT Technology Review)

9 Here’s what new tech millionaires will do with their IPO wealth ?
What a nice problem to have to grapple with! (Quartz $)

10 Dating apps’ latest wheeze? In-person events 
Well well well, it seems we’ve come full circle. (Bloomberg $)

Quote of the day

“Call us optimists, call us dreamers. Just as we’ve always done, we’re betting on people.” 

—The voiceover from a new advert from Meta, which exhorts us to be more optimistic about AI.

One More Thing

bird on a branch

BELL HUTLEY


AI is changing how we study bird migration

In a warming world increasingly full of human infrastructure that can be deadly to them, like glass skyscrapers and power lines, migratory birds are facing many existential threats. 

Scientists rely on a combination of methods to track the timing and location of their migrations, though each has shortcomings. But now, machine-learning tools are unlocking a treasure trove of acoustic data for ecologists. 

Read our story about the technology that’s making it easier to detect and identify birds and their movements.

—Christian Elliott

We can still have nice things

A place for comfort, fun, and distraction to brighten up your day. (Got any ideas? Drop me a line.)

+ It’s never too late to live your dreams. Here’s how these late bloomers did it.
+ Limbs feeling a bit tight? Try these stretches!
+ These English football fans went to the 1986 World Cup—and loved it so much they never came home.
+ How the invention of the humble paint tube revolutionized the world of art.

Machine learning methods evaluation for identification of cognitive phenotypes in multiple sclerosis and their MRI correlates

BackgroundCognitive impairment (CI) is common in multiple sclerosis (MS) yet poorly captured by conventional disability scales. Although neuropsychological assessment and magnetic resonance imaging (MRI) are routinely used separately, there is no simple clinically applicable framework integrating cognitive performance with structural brain changes to identify patients at increased risk of cognitive decline. Integrating neuropsychological testing with MRI-based atrophy metrics may yield clinically useful cognitive phenotypes with differential patterns of brain atrophy measures.MethodsData were collected from 79 patients with multiple sclerosis (PwMS) who underwent comprehensive neuropsychological assessment and brain MRI. Neuropsychological variables were subjected to a feature selection procedure based on variance and quartile coefficient of dispersion filtering, followed by Pearson correlation and mutual information (MI) analyses to generate reduced feature sets. These feature sets were used as input for unsupervised clustering with the Partitioning Around Medoids (PAM) algorithm to identify cognitive phenotypes. Differences between the resulting groups in the degree of brain atrophy measures were subsequently evaluated using appropriate statistical tests—one-way ANOVA or the Kruskal–Wallis test. Post hoc analysis was performed using a pairwise t-test, Welch’s t-test, or Wilcoxon test with the Holm-Bonferroni correction, depending on the data distribution and variance.ResultsThe feature selection procedure based on variance and mutual information identified neuropsychological features that were subsequently used for clustering. Based on these features, the PAM algorithm identified three distinct groups of PwMS that differed in their clinical characteristics, degree of brain atrophy measures, and cognitive phenotype, ranging from preserved cognition to global cognitive impairment.ConclusionThree cognitive phenotypes with differential patterns of brain atrophy measures integrate neuropsychological testing with MRI measures into a clinically applicable framework that may help bridge the gap between structural imaging findings and everyday cognitive assessment in PwMS. This approach may improve screening, enable earlier detection of CI, improve monitoring, and provide valuable information for rehabilitation planning.