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AbbVie's Cancer Drug Venetoclax Falls Short In Phase 3 Combination Trial For Myelodysplastic Syndromes

AbbVie Inc ABBV on Monday announced an update from the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).

MDS is a group of cancers in which the bone marrow doesn't produce enough healthy blood cells.

The primary outcome measure is overall survival (OS). Key secondary outcome measures include a modified overall response (mOR) and complete remission (CR).

Also Read: AbbVie Scores FDA Approval For Its Blockbuster Drug Rinvoq To Treat Type Of Arthritis

The trial did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed.

Results from the VERONA trial will be available in a future medical congress and/or publication.

The treating physician will inform any patients who received venetoclax in combination with azacitidine through participation in the MDS clinical trials.

These data do not impact any currently approved indications for venetoclax.

In the first quarter, AbbVie reported Venclexta's revenues were $665 million, up 8.3% year over year (+12.3%).

Last week, the U.S. Food and Drug Administration (FDA) approved a label expansion for AbbVie's Mavyret (glecaprevir/pibrentasvir) to include treatment of acute hepatitis C virus (HCV) infection in patients without cirrhosis or with compensated cirrhosis.

With this approval, Mavyret is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate.

HCV is a highly infectious blood-borne disease affecting the liver.

Equity research analysts on and off Wall Street typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.

Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at AbbVie, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. For AbbVie, the 200-day moving average sits at $188.78, according to Benzinga Pro, which is below the current price of $189.54. For more on charts and trend lines, see a description here.

Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.

Price Action: ABBV stock is trading lower by 1.47% to $188.06 at last check Tuesday.

Roche, AbbVie's Venclexta Stumbles Again, This Time In Myelodysplastic Syndromes

Roche and AbbVie's Venclexta, when used in combination with chemotherapy, does not improve survival in high-risk patients with myelodysplastic syndrome, adding to a growing list of setbacks for the blood cancer drug.

According to a press announcement on Monday, Venclexta plus azacitidine improved overall survival by under 10%, an effect that failed to reach statistical significance. Venclexta's survival miss will not affect any of its existing approvals, the companies insisted.

Monday's data come from the Phase III VERONA trial, a randomized study that pitted Venclexta plus azacitidine against azacitidine alone. The study enrolled more than 530 patients deemed intermediate, high or very high risk as per international assessment standards. Full data from VERONA will be available at a future scientific meeting and publication, the companies said.

Venclexta is an oral small molecule blocker of BCL-2, a protein that prevents cell death. Cancer cells overexpress BCL-2, which promotes the survival of the tumor and has been linked to treatment resistance.

Venclexta first received FDA approval in 2016 for chronic lymphocytic leukemia, garnering a handful of other approvals since then, including for acute myeloid leukemia. But further efforts to expand the drug's label have run into roadblocks. In September 2023, for instance, AbbVie and Roche revealed that the Phase III CANOVA trial of Venclexta in relapsed or refractory multiple myeloma failed to demonstrate a significant benefit in progression-free survival (PFS). CANOVA combined Venclexta with dexamethasone and compared it against pomalidomide plus dexamethasone.

Years before, in 2019, the FDA slapped a clinical hold on all multiple myeloma Venclexta trials at the time after detecting a higher rate of deaths in a Phase III trial versus placebo. The regulator lifted the pause a few months later and in 2021, the study that triggered the freeze, dubbed BELLINI, demonstrated a significant PFS benefit to Venclexta plus bortezomib—but also detected a higher risk of mortality.

Venclexta remains a strong market asset for AbbVie and Roche. It made $2.6 billion in 2024, growing nearly 16% year-on-year on an operational basis.

New Blood Test Can Detect Cancer 3 Years Before You Start Showing Symptoms

Want to B-positive about your health?

Johns Hopkins researchers have developed a cutting-edge blood test that can detect signs of cancer three years before any symptoms surface.

The breakthrough could help doctors diagnose cancer long before today's screening tools allow, giving patients a better shot at beating the disease.

Blood-based screening could one day complement existing screening methods. Vadim – stock.Adobe.Com

"Three years earlier provides time for intervention," Dr. Yuxuan Wang, an assistant professor of oncology and lead researcher of the study, said in a statement.

"The tumors are likely to be much less advanced and more likely to be curable," she added.

For the study, Wang and her colleagues analyzed blood samples from 52 people involved in a large National Institutes of Health-funded research project on cardiovascular health.

Half were later diagnosed with cancer within six months of giving blood. The rest stayed cancer-free.

The researchers ran the samples through a multicancer early detection (MCED) test, which uses ultra-sensitive sequencing to hunt for tiny shards of mutated DNA that tumors leak into the bloodstream.

It detected signs of cancer in 8 of the 26 future patients.

Cancerous tumors shed genetic material into the bloodstream. Sebastian Kaulitzki – stock.Adobe.Com

But here's the kicker: Six of those patients had older blood samples on file — and in four of them, early signs of cancer were already lurking more than three years before their diagnosis.

"This study shows the promise of MCED tests in detecting cancers very early, and sets the benchmark sensitivities required for their success," said senior author Dr. Bert Vogelstein, a professor of oncology and co-director of the Ludwig Center at Johns Hopkins.

Right now, no MCED tests are fully approved by the FDA for widespread use, though some are commercially available under looser rules as Laboratory Developed Tests.

While MCED tests aren't intended to replace standard screenings, experts say they could play an important role in spotting cancers earlier — especially those, like colon cancer, that are often diagnosed at advanced stages.

Several companies are developing MCED blood tests. Alexander Raths – stock.Adobe.Com

"Detecting cancers years before their clinical diagnosis could help provide management with a more favorable outcome," said Nickolas Papadopoulos, a professor of oncology and senior author of the study.

"Of course, we need to determine the appropriate clinical follow-up after a positive test for such cancers," he added.

Among the eight participants whose cancers the MCED test detected months before diagnosis, five died from the disease — underscoring how deadly cancer can be when caught too late.

For example, the five-year survival rate for breast cancer is 99% when detected early, but drops to less than 32% once the disease has spread, according to the American Cancer Society.

Excluding non-melanoma skin cancers, the group estimates more than 2 million new cancer cases will be diagnosed in the US in 2025 — with over 618,000 people expected to die from the disease.

That breaks down to roughly 1,700 deaths every single day.

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