How far is Johnson&Johnson's oncology business from its $50 billion revenue target?

On June 13th, Johnson&Johnson announced the results of its Phase III study on MonumenTAL-3, which evaluated the efficacy and safety of GPRC5D bispecific antibody Talvey (talquetamab) combined with Darzalex Faspro (subcutaneous injection of darzalex), with or without pomalidomide, in patients with relapsed or refractory multiple myeloma (RRMM) who had previously received at least first-line treatment.

The effect is quite clear.

Patients who receive the combination therapy of Talvey and Darzalex Faspro, whether or not combined with pomalidomide, can significantly reduce the risk of disease progression or death by up to 72% compared to the standard treatment group (Darzalex Faspro+pomalidomide+dexamethasone), and can significantly reduce the risk of death by up to 53%. At 24 months, it showed 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 therapy for multiple myeloma, and Johnson&Johnson continues to expand its presence in this field, with Talvey being a key player.

Previously, Talvey was limited to the rear battlefield, while the data from MonumenTAL-3 opened up a channel for it to advance towards the front line. Johnson&Johnson has submitted a supplementary biological product licensing application to the FDA and a Class II change application to the EMA.

Once successfully completed, Talvey will be another heavyweight chip for Johnson&Johnson to achieve its $50 billion tumor revenue target.

01、Talvey data breaks through strongly

Talvey is a bispecific T cell adapter antibody (TCE) that can simultaneously bind to CD3 receptor and G protein coupled receptor C-group 5 member D (GPRC5D) expressed on the surface of T cells. GPRC5D is one of the most promising new targets in the field of multiple myeloma in recent years. This is largely attributed to its high expression on the surface of multiple myeloma cells and non malignant plasma cells, as well as in some healthy tissues such as skin and tongue epithelial cells, and its low or no expression on normal B cells. In other words, targeting GPRC5D can locate myeloma cells while protecting healthy B cells as much as possible. In addition, the expression of GPRC5D is usually unrelated to other targets, such as BCMA, another popular target in multiple myeloma. The expression of both on myeloma cells is independent of each other, and the expression of GPRC5D is not affected by BCMA loss. 

This characteristic gives Talvey the potential for sequential treatment with BCMA targeted therapies such as BCMA CAR-T or bispecific antibodies. Talvey is currently the only approved GPRC5D targeted drug. In August 2023, Talvey received approval from both the US FDA and the European and American Commission (EC), but the approved indications were limited to second-line treatment. The patient base in the aftermarket is limited, with Talvey's annual sales of $463 million in 2025 and $150 million in the first quarter of 2026, a year-on-year increase of over 70%.

 Although the growth rate is considerable, its proportion in Johnson&Johnson's oncology business is still very low. If the data from MonumenTAL-3 can drive Talvey towards more cutting-edge treatments, it may become a major turning point for Talvey's commercialization. The MonumenTAL-3 study included three parallel treatment groups, namely Tal DP group (Talvey combined with Darzalex Faspro and pomalidomide), Tal-D group (Talvey combined with Darzalex Faspro, without pomalidomide), and control group DPd (Darzalex Faspro combined with pomalidomide and dexamethasone).

 A total of 864 patients with relapsed or refractory multiple myeloma who had received at least first-line treatment (all using lenalidomide and proteasome inhibitors) were included in the study. Among them, 85.1% were resistant to lenalidomide, 93.4% were resistant to first-line treatment, and 11.8% had received anti-CD38 antibody therapy.

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

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), while 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 of the control group DPd was 51.2%. In terms of key secondary endpoints, Tal DP and Tal-D are also overall superior to DPd. The overall response rates (ORRs) of the three groups were 88.2%, 88.5%, and 77.6%, respectively; The rates of complete remission or better (≥ CR) were 71.1%, 68.9%, and 34.5%, respectively; The proportions of patients with minimal residual disease who were negative and achieved complete remission (MRD negative ≥ CR) were 52.3%, 46.3%, and 15.9%, respectively. The OS also showed improvement in favor of the Talvey scheme. The 24 month OS rate of Tal DP group was 89.2%; The 24 month OS rate of the Tal-D group was 87.9%, while the 24 month OS rate of the control group DPd was 79.1%. In terms of safety, the overall safety of the Talvey regimen is consistent with the known data for each individual drug. It is worth noting that the serious infection risk (grade 3/4 infection incidence rate of 29.2%) in the Tal-D group and the Tal DP group (37.27%) were lower than those in the standard treatment DPd group (42.2%), and this difference has clear clinical significance. These data not only solidify Talvey's clinical value, but also provide the strongest evidence for its advancement towards frontline treatment.

02、Johnson's Myeloma Empire

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

Looking at Johnson&Johnson's existing product structure, the oncology business is undoubtedly its most certain source of growth. Johnson&Johnson CEO Joaquin Duato publicly stated during a conference call that the company's goal is to become the world's top anti-tumor enterprise by 2030 and achieve $50 billion in revenue.

Johnson&Johnson regards multiple myeloma as the core battlefield to achieve this goal. According to data from the World Health Organization, there will be over 300000 new cases of multiple myeloma worldwide in 2022, with over 30000 new cases in China, making it the second largest hematological malignancy after diffuse large B-cell lymphoma.
The Research And Markets report shows that the global market size for multiple myeloma will be $21.78 billion in 2024, and is expected to reach $40.41 billion by 2033, with a compound annual growth rate of 7.11% during the forecast period from 2025 to 2033.

A blood cancer market that grows billions of dollars annually is naturally a battleground for major MNCs. Johnson&Johnson chose to heavily deploy troops here based on two levels of judgment.

The first is at the level of clinical needs. Most patients with multiple myeloma will experience multiple relapses, and treatment options gradually narrow after each recurrence. A patient may undergo fourth line, fifth line, or even more line treatments from diagnosis to eventual death, with each line representing a new demand for medication.

The second is at the level of competitive landscape. The drug development threshold for multiple myeloma is relatively high, and the core targets are relatively concentrated - CD38, BCMA, GPRC5D, FcRH5, etc. - once a multi-target product combination advantage is formed, it is difficult for latecomers to find a breakthrough in the short term.

 Johnson&Johnson's layout over the past two decades has essentially been building a barrier constructed by time and data.

In 2003, Johnson&Johnson's proteasome inhibitor Velcade, developed in collaboration with Takeda's subsidiary, received FDA approval. The drug was highly successful and quickly became a first-line treatment for multiple myeloma. Velcade's sales exceeded $1 billion in 2008 and peaked at $2.7 billion in 2015.

The success of Velcade has shown Johnson&Johnson the powerful potential of the multiple myeloma market. In 2012, Johnson&Johnson acquired exclusive global rights to Darzalex from Genmab for $55 million. In 2015, Darzalex received FDA approval, becoming the world's first CD38 monoclonal antibody to be approved and quickly becoming a cornerstone drug for multiple myeloma.

According to a research report by Southwest Securities, Darzalex will account for 43.3% of the global multiple myeloma drug market in 2023. In the Chinese market, according to PDB sample hospital data, Darzalex sales accounted for 33.9% in 2023.

By 2025, Darzalex's global sales will reach 14.4 billion US dollars, approaching the size of the entire immunology sector. In the first quarter of 2026, Darzalex's sales reached $3.964 billion, with 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 impressive.

Afterwards, Johnson&Johnson successively laid out pipelines such as BCMA bispecific antibody (Tecwayli), GPRC5D bispecific antibody (Talvey), BCMA CAR-T (Carvykti), etc., together with Darzalex, to form the latest product matrix for multiple myeloma.

Johnson&Johnson is actively exploring the combination therapy between these drugs.

The subcutaneous formulation Darzalex Faspro approved in 2020 significantly shortened the administration time and improved patient compliance; In January 2026, the FDA approved Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients who are not suitable for autologous stem cell transplantation; In March of the same year, Tecwayli combined with Darzalex Faspro was approved for second-line treatment of relapsed or refractory multiple myeloma. The joint scheme between Talvey and Darzalex Faspro is also being promoted, and MonumenTAL-3 is its key confirmatory study.

This combination of multiple treatment stages covering the entire life cycle of patients has created market barriers far higher than those of a single drug. Biljana Naumovic, the head of Johnson&Johnson's oncology business, stated in 2023 that by the end of this decade, Johnson&Johnson is expected to become the "only pharmaceutical company with a comprehensive treatment plan for this disease".

03、Is surrounded by heroes, is Johnson&Johnson's "combination punch" strong enough?

Although Johnson&Johnson holds a leading position, there are many pursuers behind. In the field of multiple myeloma, other MNCs are also actively laying out their plans. Sanofi is one of the most important pursuers that cannot be ignored.

In 2020, its CD38 monoclonal antibody Sarclisa was approved by the FDA for use in combination with pomalidomide and dexamethasone in relapsed and refractory patients who have undergone at least second-line treatment; In 2024, Sarclisa further advances into first-line therapy and has been approved to use a combination of bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients who are not suitable for autologous stem cell transplantation. In 2025, Sarclisa's annual sales reached 588 million US dollars. Although there is still a huge gap in size compared to Darzalex, the year-on-year growth rate of over 20% also puts competitive pressure on Johnson&Johnson. On the BCMA target, competition has differentiated into several different tracks. In the field of BCMA dual antibody, Pfizer's Elrexbio (elranatamab, BCMAxCD3) received accelerated FDA approval in 2023 for the treatment of relapsed/refractory multiple myeloma, for which patients have previously undergone at least four treatments; In 2025, the FDA approved the launch of the same target dual antibody Lynozyfic (linvoseltamab gcpt) for regenerating elements, which is also indicated for adult patients with multiple myeloma who have received at least fourth line treatment but still experience recurrence or are difficult to treat. At the BCMA ADC track, GSK's Blenrep was first approved for market by the FDA and EMA in 2020 based on DREAMM-2 research data. However, in November 2022, the drug was withdrawn from the market due to failure to meet the primary endpoint in the confirmatory study (DREAMM-3). Subsequently, with the positive results of two randomized controlled phase III registration studies, DREAMM-7 and DREAMM-8, Blenrep was re approved for marketing in 2025. It is worth noting that Blenrep has experienced ocular toxic side effects in phase III studies, which has become an unavoidable weakness in its clinical promotion and a key risk management point that needs to be closely monitored in the future.

BCMA is also a popular target for CAR-T, BMS、 The CAR-T approved by Reindeer Biology and Keji Pharmaceutical are based on this target. However, at present, Carvykti's leading advantage is increasing. By 2025, Carvykti will become one of the "heavyweight bombs", generating $1.887 billion in revenue, a year-on-year increase of 95.95%, and becoming the best-selling CAR-T therapy.

In the field of GPRC5D targeting, the competitive landscape is different. Talvey is still the only approved GPRC5D targeted drug at present, with Johnson&Johnson leading the way for the time being, but newcomers are coming, and the performance of Chinese companies is particularly outstanding.

Weili Zhibo's LBL-034 (GPRC5D x CD3 dual antibody) has advanced to phase II clinical stage and obtained FDA fast track qualification in January 2026. According to the Phase I/II data released by Weili Libo at the American Society of Hematology (ASH) Annual Meeting in 2025, the objective response rate (ORR) for 400-1200 μ g/kg (n=40) was 82.5%, ≥ complete response (CR) was 52.5%, ≥ very good partial response (VGPR) was 72.5%, and the negative rate for minimal residual lesions (MRD) was 80.0%; At an ORR and ≥ CR rate of 800 μ g/kg, the rates were as high as 90.9% and 63.6%, respectively.

Xinda Biotech's IBI3003 (GPRC5D/BCMA/CD3 tertiary antibody) also obtained FDA fast track qualification in January of this year. According to the data released at the ASH Annual Meeting in 2025, the ORR of 24 patients treated with doses ≥ 120 μ g/kg was 83.3%, including 4 cases of sCR, 7 cases of VGPR, and 9 cases of PR. Among them, 10 patients with extramedullary lesions (EMD) had an ORR of 80%, and 9 patients who had previously received anti BCMA and/or anti GPRC5D treatment had an ORR of 77.8%.

In addition, Johnson&Johnson also has a three antibody JNJ-79635322 (GPRC5D/BCMA/CD3) under development. In phase I data, the ORR of 27 patients reached 100%, the complete response rate was 77.8%, and the 12-month PFS rate was 96.3%.

The opponent is sharpening their knives, but Johnson&Johnson has already laid out a series of "combination punches" - from CD38 to BCMA and then to GPRC5D, from dual antibody, triple antibody to CAR-T, making it difficult for newcomers to find a single point breakthrough gap.

Return to MonumenTAL-3. The significance of this study goes beyond just a new set of clinical data. It marks a crucial step forward for GPRC5D targeted therapy from the back line to the front line, and further strengthens Johnson&Johnson's product moat in the field of multiple myeloma. When the four products Talvey, Tecwayli, Carvykti, and Darzalex are validated in the market, it is becoming increasingly difficult for other pharmaceutical companies to compete head-on without cross combination.

And all of this will ultimately converge into Johnson&Johnson's confidence in achieving its targets of billions of revenue and $50 billion in cancer revenue - the victory of MonumenTAL-3 is not only Talvey's victory, but also another coronation of Johnson&Johnson as the "king of multiple myeloma".

Reference article:
1. Johnson&Johnson made a big push and "gathered" a giant in multiple myeloma; Amino observation
2. Multiple myeloma: BCMA targeted therapy pushed to the forefront; 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, heading towards 100 billion