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JNJ's Combo Therapy Shows Strong Phase III Efficacy in Prostate Cancer
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Key Takeaways
JNJ's combo therapy showed significant rPFS and TSP improvements in mCSPC patients with HRR alterations.
BRCA-altered patients saw a 48% drop in progression risk and a 56% drop in symptom worsening risk.
JNJ-5322 in early MM study showed 86.1% ORR overall and 100% in treatment-naive patients at RP2D.
Johnson & Johnson (JNJ - Free Report) announced positive top-line data from a late-stage study evaluating the combination of niraparib, a PARP inhibitor, and abiraterone acetate, a CYP17 inhibitor, plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations, including BRCA.
JNJ’s phase III AMPLITUDE study results demonstrated a clinically meaningful and statistically significant improvement in both radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP), along with an early trend toward improved overall survival (OS). These findings underscore the potential of the combination therapy to delay disease progression and symptom worsening in this patient population.
Notably, this is the first phase III study to show clinical benefit with a PARP-based combination mCSPC.
Johnson & Johnson currently markets the niraparib and abiraterone acetate combo, under the brand name Akeega, together with prednisone or prednisolone in the United States and the EU for treating BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Additional marketing authorization applications seeking the approval of Akeega for the mCRPC indication are currently under review across several geographies.
Year to date, shares of Johnson & Johnson have gained 6.8% against the industry’s 3.2% decline.
Image Source: Zacks Investment Research
JNJ’s Phase III Prostate Cancer Study Data in Detail
In the phase III AMPLITUDE study involving 696 patients with mCSPC and HRR alterations, the niraparib plus AAP combo therapy met its primary endpoint by significantly improving rPFS. Patients with BRCA alterations experienced the most pronounced benefit, with the median rPFS not reached in the niraparib group compared to 26 months in the placebo group, representing a 48% reduction in the risk of radiographic progression or death. Across the broader HRR-altered population, median rPFS was also not reached with the niraparib combo compared to 29.5 months in the placebo arm, reflecting a 37% risk reduction.
Additionally, the treatment significantly delayed symptomatic progression, reducing the risk by 56% in BRCA-altered patients and by 50% in the overall HRR-altered population. This suggests patients had a longer time before experiencing worsening symptoms that would require further intervention. An early interim analysis also showed a favorable trend toward improved OS upon treatment with the niraparib/AAP combo, with a 25% risk reduction in BRCA patients and 21% in those with HRR alterations, though these results were not yet statistically significant. Further follow-up is ongoing to confirm survival outcomes.
The combo regimen demonstrated an acceptable safety profile in the phase III AMPLITUDE study and was consistent with that observed in prior clinical studies.
Per Johnson & Johnson, about 25% of patients with mCSPC have HRR alterations, with about half being BRCA. These patients typically experience faster disease progression and poorer outcomes. JNJ’s AMPLITUDE study is the first to show that combining a PARP inhibitor with an androgen receptor pathway inhibitor (abiraterone acetate) both delays disease progression and postpones the onset of symptoms in HRR-altered mCSPC, supporting this combination as a new treatment option for these patients.
JNJ Reports Early Results From Phase I Multiple Myeloma Study
In a separate press release, Johnson & Johnson reported initial results from an early-stage dose-escalating study of its investigational candidate, JNJ-79635322 (JNJ-5322), in patients with relapsed or refractory multiple myeloma (MM).
In the first-in-human phase I MM study, 126 patients received the candidate with a median follow-up of 8.2 months. The 100 mg dose of JNJ-5322 administered every four weeks was established as the recommended phase 2 dose (RP2D).
Among the 36 patients who received the RP2D, the overall response rate (ORR) reached 86.1%. Notably, in the subgroup of 27 patients who had not previously received therapies targeting BCMA or GPRC5D, the ORR was 100% at the RP2D.
JNJ-5322 is a novel TsAb that builds upon the success of earlier bispecific therapies like teclistamab and talquetamab. Unlike its predecessors, JNJ-5322 is a single molecule that targets three distinct proteins simultaneously — BCMA and GPRC5D on MM cells, and CD3 on T-cells. By engaging two tumor antigens at once, it aims to address tumor heterogeneity and reduce the risk of treatment resistance.
In the phase I MM study of JNJ-5322, cytokine release syndrome was the most frequently reported adverse event, occurring in 59% of patients, though all cases were mild to moderate in severity. Serious infections were observed in 28% of patients. Additionally, five patients experienced dose-limiting toxicities, and there were four treatment-related deaths, including one linked to adenoviral encephalitis associated with the drug.
Based on the above data, Johnson & Johnson is currently gearing up to advance JNJ-5322 to the next phase in the clinical development process for treating MM.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 45.9%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 14.4%.
LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.
In the past 60 days, estimates for Amarin’s loss per share for 2025 have narrowed from $5.00 to $2.78. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $2.04. Year to date, shares of AMRN have gained 23.2%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.
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JNJ's Combo Therapy Shows Strong Phase III Efficacy in Prostate Cancer
Key Takeaways
Johnson & Johnson (JNJ - Free Report) announced positive top-line data from a late-stage study evaluating the combination of niraparib, a PARP inhibitor, and abiraterone acetate, a CYP17 inhibitor, plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations, including BRCA.
JNJ’s phase III AMPLITUDE study results demonstrated a clinically meaningful and statistically significant improvement in both radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP), along with an early trend toward improved overall survival (OS). These findings underscore the potential of the combination therapy to delay disease progression and symptom worsening in this patient population.
Notably, this is the first phase III study to show clinical benefit with a PARP-based combination mCSPC.
Johnson & Johnson currently markets the niraparib and abiraterone acetate combo, under the brand name Akeega, together with prednisone or prednisolone in the United States and the EU for treating BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Additional marketing authorization applications seeking the approval of Akeega for the mCRPC indication are currently under review across several geographies.
Year to date, shares of Johnson & Johnson have gained 6.8% against the industry’s 3.2% decline.
Image Source: Zacks Investment Research
JNJ’s Phase III Prostate Cancer Study Data in Detail
In the phase III AMPLITUDE study involving 696 patients with mCSPC and HRR alterations, the niraparib plus AAP combo therapy met its primary endpoint by significantly improving rPFS. Patients with BRCA alterations experienced the most pronounced benefit, with the median rPFS not reached in the niraparib group compared to 26 months in the placebo group, representing a 48% reduction in the risk of radiographic progression or death. Across the broader HRR-altered population, median rPFS was also not reached with the niraparib combo compared to 29.5 months in the placebo arm, reflecting a 37% risk reduction.
Additionally, the treatment significantly delayed symptomatic progression, reducing the risk by 56% in BRCA-altered patients and by 50% in the overall HRR-altered population. This suggests patients had a longer time before experiencing worsening symptoms that would require further intervention. An early interim analysis also showed a favorable trend toward improved OS upon treatment with the niraparib/AAP combo, with a 25% risk reduction in BRCA patients and 21% in those with HRR alterations, though these results were not yet statistically significant. Further follow-up is ongoing to confirm survival outcomes.
The combo regimen demonstrated an acceptable safety profile in the phase III AMPLITUDE study and was consistent with that observed in prior clinical studies.
Per Johnson & Johnson, about 25% of patients with mCSPC have HRR alterations, with about half being BRCA. These patients typically experience faster disease progression and poorer outcomes. JNJ’s AMPLITUDE study is the first to show that combining a PARP inhibitor with an androgen receptor pathway inhibitor (abiraterone acetate) both delays disease progression and postpones the onset of symptoms in HRR-altered mCSPC, supporting this combination as a new treatment option for these patients.
JNJ Reports Early Results From Phase I Multiple Myeloma Study
In a separate press release, Johnson & Johnson reported initial results from an early-stage dose-escalating study of its investigational candidate, JNJ-79635322 (JNJ-5322), in patients with relapsed or refractory multiple myeloma (MM).
In the first-in-human phase I MM study, 126 patients received the candidate with a median follow-up of 8.2 months. The 100 mg dose of JNJ-5322 administered every four weeks was established as the recommended phase 2 dose (RP2D).
Among the 36 patients who received the RP2D, the overall response rate (ORR) reached 86.1%. Notably, in the subgroup of 27 patients who had not previously received therapies targeting BCMA or GPRC5D, the ORR was 100% at the RP2D.
JNJ-5322 is a novel TsAb that builds upon the success of earlier bispecific therapies like teclistamab and talquetamab. Unlike its predecessors, JNJ-5322 is a single molecule that targets three distinct proteins simultaneously — BCMA and GPRC5D on MM cells, and CD3 on T-cells. By engaging two tumor antigens at once, it aims to address tumor heterogeneity and reduce the risk of treatment resistance.
In the phase I MM study of JNJ-5322, cytokine release syndrome was the most frequently reported adverse event, occurring in 59% of patients, though all cases were mild to moderate in severity. Serious infections were observed in 28% of patients. Additionally, five patients experienced dose-limiting toxicities, and there were four treatment-related deaths, including one linked to adenoviral encephalitis associated with the drug.
Based on the above data, Johnson & Johnson is currently gearing up to advance JNJ-5322 to the next phase in the clinical development process for treating MM.
Johnson & Johnson Price and Consensus
Johnson & Johnson price-consensus-chart | Johnson & Johnson Quote
JNJ’s Zacks Rank and Stocks to Consider
Johnson & Johnson currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Bayer (BAYRY - Free Report) , Lexicon Pharmaceuticals (LXRX - Free Report) and Amarin (AMRN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 45.9%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 14.4%.
LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.
In the past 60 days, estimates for Amarin’s loss per share for 2025 have narrowed from $5.00 to $2.78. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $2.04. Year to date, shares of AMRN have gained 23.2%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.