CHMP建议批准强生Talvey(talquetamab)联合daratumumab用于复发/难治多发性骨髓瘤更早线(二线起)治疗

If approved, TALVEY
®
plus daratumumab will be the only GPRC5D-targeting bispecific antibody combination therapy for relapsed or refractory multiple myeloma as early as second line
CHMP recommendation based on Phase 3 results where talquetamab and daratumumab, with or without pomalidomide,
showed progression-free survival of up to 81% and overall survival of up to 89% at 24 months
1
BEERSE, BELGIUM, Oct. 16, 2026 (GLOBE NEWSWIRE) --
Johnson & Johnson, a worldwide leader in multiple myeloma, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the approval of an indication extension of TALVEY
®
(talquetamab). The recommendation is for talquetamab plus daratumumab with or without pomalidomide for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), who have received at least one prior therapy.
Combination of talquetamab plus daratumumab offers a novel target approach to RRMM treatment, with potential to spare healthy immune cells
Talquetamab targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body).
2
GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-cells
.
2
Talquetamab works by targeting myeloma cells while largely sparing healthy B-cells.
2
With daratumumab priming the immune system for enhanced talquetamab activity, the combination benefits from complementary mechanisms of action, reinforcing the potential effectiveness of this approach in multiple myeloma.
2
,
3
,
4
Expert and company perspectives support talquetamab use earlier in the treatment pathway
“MonumenTAL-3 demonstrated significant improvements in progression-free survival, overall survival, response rates and depth of response with the combination of talquetamab and daratumumab,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “For patients facing their first relapse, this combination has the potential to provide deep responses and keep their disease under control for longer at a critical point in their treatment journey. This CHMP recommendation reflects the continued evolution of the talquetamab programme in multiple myeloma, and further strengthens the potential of talquetamab-based therapies as early as second line, building on our commitment to generate data that can help inform treatment choices based on patients’ prior therapies and disease characteristics.”
“At Johnson & Johnson, our strategy is grounded in pursuing differentiated immunotherapy approaches earlier in the disease course to address diverse patient characteristics and the evolving complexity of multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “This off-the-shelf, immunotherapy-based combination leverages the power of our portfolio by bringing together talquetamab with the well-established therapy of daratumumab. By simultaneously targeting GPRC5D and CD38, our goal is to deliver deeper and longer lasting responses for patients.”
Talquetamab combination has delivered significant clinical benefits from second line
The MonumenTAL-3 study evaluated talquetamab plus daratumumab (Tal-D) or Tal-D and pomalidomide (Tal-DP) compared to daratumumab plus pomalidomide and dexamethasone (DPd) in patients with RRMM who have received at least one prior line of therapy.
5
At a median follow-up of two years (24.6 months), results showed significant improvement in progression-free survival (PFS) for Tal-DP (hazard ratio [HR], 0.28; 95% confidence interval [CI], 0.20-0.40;
p
<0.0001) and Tal-D (HR, 0.33; 95% CI, 0.24-0.46;
p
<0.0001).
2
At 24 months, Tal-DP showed a PFS rate of 81.3% and Tal-D showed a PFS rate of 77.6%.
2
All participants (N=864) were previously exposed to lenalidomide and a proteasome inhibitor and received at least one prior line of therapy.
2
Most patients enrolled were refractory to lenalidomide (85.1%) and their last line of therapy (93.4%), and some were exposed to an anti-CD38 antibody (11.8%).
1
Statistically significant improvements compared to DPd were observed across key secondary endpoints of overall response rate (ORR), complete response or better (≥CR) and minimal residual disease (MRD)-negative ≥CR (10
-5
, next-generation sequencing [NGS]) for Tal-DP and Tal-D.
2
ORRs (88.2%, 88.5%, 77.6%), ≥CR rates (71.1%, 68.9%, 34.5%) and MRD-negative ≥CR rates (52.3%, 46.3%, 15.9%) were significantly higher for Tal-DP and Tal-D vs DPd, respectively, after two years median follow-up.
2
Clinically meaningful improvement in overall survival (OS) was shown with Tal-DP (HR, 0.47; 95% CI, 0.30-0.73;
p
=0.0006) and Tal-D (HR, 0.51; 95% CI, 0.33-0.78;
p
=0.0015) vs DPd.
2
At 24 months, Tal-DP delivered an OS rate of 89.2% and Tal-D delivered an OS rate of 87.9%.
2
Safety profiles consistent with the known safety profiles of each monotherapy
The overall safety profiles for the talquetamab plus daratumumab treatment arms were consistent with the known safety profiles of each monotherapy.
2
Overall, rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable across treatment arms (94.9% with Tal-DP, 74.8% with Tal-D and 91.5% with DPd).
1
Infections occurred at rates of 87.3% (Tal-DP), 84.3% (Tal-D) and 83.0% (DPd).
2
Tal-D had the lowest rate of Grade 3/4 infections (29.2%), followed by Tal-DP (37.7%) and DPd (42.2%).
2
There were some instances of Grade 5 adverse events (AEs) across the entire population of the study; the Tal-DP arm saw the fewest (1.8%), followed by Tal-D (4.0%) and DPd (4.6%), with approximately 0.7% (Tal-DP), 1.5% (Tal-D) and 1.8% (DPd) due to infections.
1
Treatment discontinuations due to AEs occurred in 10.5% of Tal-DP, 8.0% of Tal-D and 6.7% of DPd patients.
2
At data cutoff; 70.3% (Tal-DP), 69.7% (Tal-D) and 47.3% (DPd) of patients remained on study treatment.
2
About the MonumentTAL-3 Study
The MonumenTAL-3 (
NCT05455320
) study is an ongoing Phase 3 study of talquetamab in combination with daratumumab subcutaneous (SC) with or without pomalidomide compared to daratumumab SC combined with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.
5
The primary endpoint is progression-free survival (PFS) and secondary endpoints include overall response rate (ORR), complete response or better (≥CR), minimal residual disease (MRD)-negative ≥CR (10
-5
by next-generation sequencing), overall survival (OS) and safety.
5
The MonumenTAL-3 study is a part of the MonumenTAL clinical programme, which includes exploring the potential of talquetamab as a combination regimen.
5
About Talquetamab
Talquetamab
received
conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
6
The U.S. FDA also
granted
talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
7
Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors.
6
To date, more than 11,000 patients have been treated with talquetamab worldwide.
8
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the
Summary of Product Characteristics
. In line with the European Medicine Agency’s regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring.
▼ In line with EMA regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring.
6
About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.
In
August 2012
, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide.
9
Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.
10
,
11
Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.
11
,
12
Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE
®
drug delivery technology.
11
CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.
11
,
13
Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.
11
Daratumumab may also have an effect on normal cells.
11
Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.
14
,
15
,
16
,
17
,
18
,
19
,
20
,
21
,
22
,
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For further information on daratumumab, please see the Summary of Product Characteristics at:
https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf
.
About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.
24
,
25
In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.
26
,
27
In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died.
28
Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.
29
,
30
,
31
Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.
32
About Johnson & Johnson’s Multiple Myeloma Portfolio
Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies.
Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses.
Through ongoing research and a robust clinical programme, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at
https://www.jnj.com/innovativemedicine/emea/
. Follow us at
www.linkedin.com/company/jnj-innovative-medicine-emea
.
Cautions Concerning Forward-Looking Statements
This press release
contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of talquetamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at
www.sec.gov
,
www.jnj.com
,
www.investor.jnj.com
or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Key Search Terms
MonumenTAL-3 clinical trial
TALVEY
Talquetamab
Talquetamab plus daratumumab
Relapsed and or refractory multiple myeloma (RRMM)
Early relapse multiple myeloma
Second-line multiple myeloma treatment
First relapse therapy for multiple myeloma
Treatment resistance in multiple myeloma
Progression-free survival (PFS) in multiple myeloma
Overall survival (OS) in multiple myeloma
Multiple myeloma
Bispecific antibody therapy
BCMA-targeted bispecific therapy
EMEA haematology pipeline
Multiple myeloma innovation
Multiple myeloma treatment
END
References:
1
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2
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®
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®
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J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026.
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