Johnson & Johnson Advances Toward $50 Billion Oncology Revenue Goal with Positive Phase III MonumenTAL-3 Data for Talvey Combination in Earlier-Line Multiple Myeloma

Jun 16, 2026 21:05 CST Updated 21:05

Johnson & Johnson

Medical Device R&D and Manufacturer

How Far Is Johnson & Johnson’s Oncology Business From Its $50 Billion Revenue Target?

On June 13, Johnson & Johnson announced the results of the Phase III MonumenTAL-3 study, which evaluated the GPRC5D bispecific antibody Talvey.（talquetamab）In combination with Darzalex Faspro(Daratumumab Subcutaneous Injection), with or without pomalidomide, for the treatment of relapsed or refractory multiple myeloma in patients who have received at least one prior line of therapy（RRMM）Efficacy and Safety in Patients.

EfficacyThe results are quite clear.

Patients receiving the combination regimen of Talvey and Darzalex Faspro, with or without pomalidomide, and the standard treatment group(Darzalex Faspro + Pomalidomide + Dexamethasone)In comparison, it can significantly reduce the risk of disease progression or death by up to 72%, and significantly reduce the risk of death by up to 53%. At 24 months, it demonstrated a progression-free survival rate of up to 81% and an overall survival rate of up to 89%.

Darzalex has been established as the standard of care for multiple myeloma, while Johnson & Johnson continues to strengthen its footprint in this therapeutic area, with Talvey serving as a key strategic asset.

Previously，Talvey was previously confined to later-line settings, but data from MonumenTAL-3 have paved the way for its advancement into earlier lines of therapy. Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA and a Type II variation application to the EMA.

Once it clears the regulatory hurdle, Talvey will become another major asset for Johnson & Johnson in its push to achieve a $50 billion oncology revenue target.

TONACEA

Talvey Data Breaks Through Strongly

Talvey is a bispecific T-cell engager antibody（TCE）, which can simultaneously bind to the CD3 receptor expressed on the surface of T cells and Class C Group 5 Member D of the G protein-coupled receptors（GPRC5D）Combination.

GPRC5D isOne of the most promising new targets in the field of multiple myeloma in recent years. This is largely attributable to itson the surface of multiple myeloma cells and non-malignant plasma cells, as well as in some healthy tissues(such as epithelial cells of the skin and tongue)Moderate to high expression, with no or low expression on normal B cells. In other words, targeting GPRC5DCan bePositioningwhile targeting myeloma cells, protect healthy B cells as much as possible.

Additionally, GPRC5D expression is generally independent of other targets, such as BCMA, another prominent target in multiple myeloma. The expression of these two markers on myeloma cells is mutually independent, and GPRC5D expression is not affected by the loss of BCMA. This characteristic enables Talvey to be combined with BCMA-targeted therapies(e.g., BCMA CAR-T or bispecific antibodies)Possesses the potential for sequential therapy.

Talvey is currently the only approved GPRC5D-targeted therapy. In August 2023, Talvey received approval from the U.S. FDA and the European Commission, respectively.（EC）Approved, but the approved indication is limited to later-line treatment.

The patient population in the later-line market is limited. Talvey’s full-year sales in 2025 amounted to $463 million, reaching $150 million in the first quarter of 2026, representing a year-over-year increase of over 70%. Although the growth rate is considerable, its contribution to Johnson & Johnson’s oncology business remains minimal.

If the MonumenTAL-3 data can propel Talvey into earlier-line treatment settings, it could become a major turning point in the commercialization of Talvey.

The MonumenTAL-3 study included three parallel treatment arms, namely the Tal-DP arm(Talvey in combination with Darzalex Faspro and pomalidomide), Tal-D Group(Talvey combined with Darzalex Faspro, excluding pomalidomide)and the control group DPd(Darzalex Faspro in combination with pomalidomide and dexamethasone)。

The study included a total of 864 patients who had previously received at least one line of therapy.(All received lenalidomide and proteasome inhibitors)patients with relapsed or refractory multiple myeloma, of whom 85.1% were refractory to lenalidomide, 93.4% were refractory to the last line of therapy, and 11.8% had previously received anti-CD38 antibody therapy.

Compared with the DPd group, the risk of disease progression or death was significantly reduced by 72% in the Tal-DP group and by 67% in the Tal-D group.

At 24 months, the PFS rate in the Tal-DP group was 81.3%.（HR 0.28，95% CI 0.20-0.40，p<0.0001）, the PFS rate in the Tal-D group was 77.6%（HR 0.33，95% CI 0.24-0.46，p<0.0001）。The 24-month PFS rate for DPd in the control group was 51.2%.

Regarding key secondary endpoints, Tal-DP and Tal-D both demonstrated comprehensive superiority over DPd. The overall response rates in the three groups（ORR）88.2%, 88.5%, and 77.6%, respectively; complete response or better（≥CR）The rates were 71.1%, 68.9%, and 34.5%, respectively; minimal residual disease-negative and achieving complete remission(MRD-negative ≥ CR)The proportions were 52.3%, 46.3%, and 15.9%, respectively.

OS also demonstrated improvement favoring the Talvey regimen. The 24-month OS rate was 89.2% in the Tal-DP group and 87.9% in the Tal-D group, compared with 79.1% in the DPd control group.

In terms of safety, the overall safety profile of Talvey-containing regimens is consistent with the known data for each individual agent. Notably, the risk of serious infections in the Tal-D group(Incidence of grade 3/4 infections: 29.2%)and the Tal-DP group（37.27%）DPd Group Below Standard of Care（42.2%）, this difference is clinically significant.

These data not only solidify the clinical value of Talvey but also provide the strongest evidence for its advancement into frontline therapy.

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Johnson & Johnson's Myeloma Empire

In a previous earnings conference call, Johnson & Johnson provided full-year 2026 revenue guidance of $100 billion to $101 billion—significantly higher than the $94.2 billion reported in 2025 and exceeding the average analyst estimate of $98.88 billion.

An Overview of Johnson & JohnsonIn the current product portfolio, the oncology business is undoubtedlyitsThe Most Certain Source of Growth. Johnson & Johnson CEO Joaquin Duato publicly stated during a conference call that the company aims to become the world’s leading oncology enterprise by 2030, achieving $50 billion in revenue.

Johnson & Johnson views multiple myeloma as a core battleground for achieving this goal. According to World Health Organization data, there were over 300,000 new cases of multiple myeloma globally in 2022, with more than 30,000 new cases in China, making it the second most common hematologic malignancy after diffuse large B-cell lymphoma.

According to a report by Research And Markets, the global multiple myeloma market size was $21.78 billion in 2024 and is projected to reach $40.41 billion by 2033, with a compound annual growth rate (CAGR) of 7.11% during the forecast period from 2025 to 2033.

The blood cancer market, which grows by billions of dollars annually, is naturally a fiercely contested arena for major multinational corporations (MNCs). Johnson & Johnson has chosen to heavily invest in this sector, based on judgments made at two levels.

First, from the perspective of clinical needs. Most patients with multiple myeloma experience multiple relapses, and treatment options gradually narrow after each relapse. A patient may undergo four, five, or even more lines of therapy from diagnosis to death, with each line representing a new demand for drugs.

Second is the competitive landscape. The threshold for drug development in multiple myeloma is high, with core targets being relatively concentrated—such as CD38, BCMA, GPRC5D, and FcRH5. Once a multi-target product portfolio advantage is established, it is difficult for latecomers to find a breakthrough in the short term. Johnson & Johnson’s strategic layout over the past two decades has essentially been building a barrier fortified by time and data.

In 2003, the proteasome inhibitor bortezomib was developed in collaboration between Johnson & Johnson and a Takeda subsidiary.（Velcade）Following FDA approval, the drug achieved remarkable success and rapidly became a first-line treatment for multiple myeloma. In 2008, Velcade’s sales surpassed $1 billion, reaching a peak of $2.7 billion in 2015.

The Success of Velcade，This demonstrated to Johnson & Johnson the significant potential of the multiple myeloma market. In 2012, Johnson & Johnson acquired the global exclusive rights to Darzalex from Genmab for $55 million. In 2015, Darzalex received FDA approval as the first approved CD38 monoclonal antibody worldwide and quickly became a cornerstone therapy for multiple myeloma.

Southwest Securities’ research report pointed out that in the global multiple myeloma drug market in 2023, Darzalex accounted for as high as 43.3% of sales. In the Chinese market, according to sample hospital data from PDB, Darzalex accounted for 33.9% of sales in 2023.

In 2025, global sales of Darzalex reached $14.4 billion, approaching the entire size of the immunology segment. In the first quarter of 2026, Darzalex sales amounted to $3.964 billion, representing a year-on-year growth of approximately 20%. For a drug that has been on the market for over 10 years, this growth rate is remarkable.

Since then, Johnson & Johnson has successively laid out its BCMA bispecific antibody portfolio.（Tecvayli）, GPRC5D bispecific antibody（Talvey）、BCMA CAR-T（Carvykti）pipeline, together with Darzalex, constitutes the latest product portfolio for multiple myeloma.

Johnson & JohnsonMeanwhileActively exploring combination regimens of these drugs.

Darzalex Faspro, a subcutaneous formulation approved in 2020，Significantly reduced administration time, improving patient compliance; In January 2026, the FDA approved Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients ineligible for autologous stem cell transplantation; In March of the same year, Tecvayli combined with Darzalex Faspro was approved for second-line treatment of relapsed or refractory multiple myeloma. The combination regimen of Talvey and Darzalex Faspro is also under development, with MonumenTAL-3 being its pivotal confirmatory study.

This comprehensive portfolio, spanning multiple stages of patient treatment throughout the disease lifecycle, establishes market barriers far higher than those of any single drug. Biljana Naumovic, Head of Oncology at Johnson & Johnson, stated in 2023 that by the end of this decade, Johnson & Johnson is poised to become “the only pharmaceutical company with a comprehensive treatment solution for this disease.”

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Surrounded by Competitors, Is Johnson & Johnson’s “Combo Punch” Strong Enough?

Although Johnson & Johnson holds a leading position, it faces numerous competitors. In the field of multiple myeloma, other multinational corporations (MNCs) are also intensively advancing their strategic layouts.

Sanofi is the most formidable contender among them.

In 2020, its CD38 monoclonal antibody, Sarclisa, received FDA approval in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma who had received at least two prior lines of therapy. In 2024, Sarclisa further advanced into first-line treatment, gaining approval in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients who are ineligible for autologous stem cell transplantation.

In 2025, Sarclisa’s annual sales reached $588 million. Although this figure remains significantly lower than that of Darzalex, its year-over-year growth rate of over 20% has exerted competitive pressure on Johnson & Johnson.

On the BCMA target,Competition has differentiated into several distinct tracks.。

In the field of BCMA bispecific antibodies, in 2023, Pfizer's Elrexfio（elranatamab，BCMAxCD3）Received FDA accelerated approval for the treatment of relapsed/refractory multiple myeloma in patients who have previously undergone at least four lines of therapy; in 2025, the FDA approved Regeneron’s bispecific antibody targeting the same mechanism, Lynozyfic.（linvoseltamab-gcpt）Marketing approval was granted for the same indication: adult patients with multiple myeloma who have relapsed or are refractory after receiving at least four prior lines of therapy.

In the BCMA ADC landscape, GSK’s Blenrep received its initial FDA and EMA approvals in 2020 based on data from the DREAMM-2 study. However, in November 2022, the drug was withdrawn due to confirmatory study（DREAMM-3）Withdrawn from the market due to failure to meet the primary endpoint. Subsequently, based on the positive results from two randomized, controlled Phase III registration trials, DREAMM-7 and DREAMM-8, Blenrep was reapproved for marketing in 2025. Notably, ocular toxicity adverse events were observed with Blenrep in the Phase III studies, representing an unavoidable limitation in its clinical adoption and a key focus for subsequent risk management.

BCMA is also a popular target for CAR-T therapies; the CAR-T products approved for BMS, Legend Biotech, and CARsgen Therapeutics are all based on this target. However, Carvykti’s leading advantage is growing increasingly significant. In 2025, Carvykti joined the ranks of “blockbuster” drugs, generating $1.887 billion in revenue, a year-on-year increase of 95.95%, making it the best-selling CAR-T therapy.

In the GPRC5D-targeted therapy landscape, the competitive dynamics are distinct. Talvey remains the only approved GPRC5D-targeted drug to date, with Johnson & Johnson currently holding the lead; however, new entrants are rapidly emerging, and Chinese companies are demonstrating particularly strong performance.

Weili Zhibo's LBL-034(GPRC5D x CD3 bispecific antibody)Advanced to Phase II clinical trials; granted FDA Fast Track designation in January 2026. According to Velocibio at the 2025 American Society of Hematology（ASH）Phase I/II data presented at the annual meeting, 400–1200 μg/kg（n=40）, Objective Response Rate（ORR）82.5%, ≥ complete response（CR）52.5%, ≥ very good partial response（VGPR）72.5%, minimal residual disease（MRD）The negative rate was 80.0%; at a dose of 800 μg/kg, the ORR and ≥CR rates were as high as 90.9% and 63.6%, respectively.

Innovent Biologics' IBI3003(GPRC5D/BCMA/CD3 Trispecific Antibody)It also received FDA Fast Track designation in January of this year. Data presented at the 2025 ASH Annual Meeting showed that among 24 patients treated with a dose of ≥120 μg/kg, the overall response rate (ORR) was 83.3%, including 4 stringent complete responses (sCR), 7 very good partial responses (VGPR), and 9 partial responses (PR); 10 of these patients had extramedullary disease.（EMD）The ORR in patients reached 80%, and the ORR in 9 patients who had previously received anti-BCMA and/or anti-GPRC5D therapy reached 77.8%.

In addition, Johnson & Johnson itself has a triple antibody JNJ-79635322.（GPRC5D/BCMA/CD3）Under investigation: In Phase I data, the ORR among 27 patients reached 100%, with a complete response rate of 77.8% and a 12-month PFS rate of 96.3%.

While competitors sharpen their knives, Johnson & Johnson has long established a multi-layered strategic array—spanning from CD38 to BCMA and then to GPRC5D, and encompassing bispecific antibodies, trispecific antibodies, and CAR-T therapies. This comprehensive “combination punch” leaves latecomers with little room for single-point breakthroughs.

Returning to MonumenTAL-3. The significance of this study extends beyond a new set of clinical data. It marks a critical step forward for GPRC5D-targeted therapies, moving from later-line to earlier-line treatment, and further strengthens Johnson & Johnson’s competitive moat in the multiple myeloma space. With Talvey, Tecvayli, Carvykti, and Darzalex all market-validated, it is becoming increasingly difficult for other pharmaceutical companies to compete head-on without leveraging cross-combination strategies.

All of this ultimately converges to bolster Johnson & Johnson’s confidence in achieving its ambitious targets of $100 billion in total revenue and $50 billion in oncology sales. The success of MonumenTAL-3 is not merely a victory for Talvey, but also another coronation for Johnson & Johnson as the “King of Multiple Myeloma.”

Reference Article:

1. Johnson & Johnson’s Big Sprint: “Cobbling Together” a Multiple Myeloma Giant; Amino Acid Observation

2. Multiple Myeloma: BCMA-Targeted Therapies Move to the Frontline; Southwest Securities

3、EHA: J&J sharpens myeloma edge as Talvey, Darzalex Faspro combo proves its worth in earlier disease stage；Fierce Pharma

4. Johnson & Johnson Announcement

5、Johnson & Johnson: On the Path to $100 Billion

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