Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE:JNJ) announced significant results from the Phase 3 CEPHEUS study, evaluating DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients ineligible for transplant or with deferred transplant. The study showed:

- 60.9% improvement in minimal residual disease (MRD) negativity rate
- 43% reduction in the risk of progression or death
- Significantly increased depth of response with higher rates of complete response or better

At a median follow-up of 58.7 months, D-VRd demonstrated superior efficacy compared to VRd alone, with an overall MRD-negativity rate of 60.9% vs 39.4%. The study also showed a significant reduction in the risk of progression or death, with median progression-free survival not reached for D-VRd vs 52.6 months for VRd.

Johnson & Johnson (NYSE: JNJ) announced updated results from the Phase 1b RedirecTT-1 study evaluating the combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) in patients with relapsed or refractory multiple myeloma (RRMM). The study showed:

- Overall response rate (ORR) of 79.5% and complete response or better (CR+) rate of 52.3%
- 18-month duration of response (DOR) of 85.9%
- 18-month progression-free survival (PFS) rate of 69.8%

In patients with extramedullary disease (EMD), the combination demonstrated an ORR of 61.1% and CR+ rate of 33.3%. The safety profile was consistent with known profiles of each agent as monotherapy, with manageable side effects.

Johnson & Johnson announced updated results from the Phase 1b TRIMM-2 study evaluating TALVEY® (talquetamab-tgvs) combined with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and pomalidomide in relapsed or refractory multiple myeloma patients. The study showed an overall response rate (ORR) of 82 percent. In the weekly dosing arm, the ORR was 100 percent, with 56 percent achieving complete response or better. The biweekly arm achieved 76 percent ORR. The median duration of response in the biweekly arm was 26.4 months, with median progression-free survival of 20.3 months. The safety profile reflected known profiles of the individual therapies, with manageable side effects. These results support further investigation of TALVEY® in combination with DARZALEX FASPRO®, currently being studied in the Phase 3 MonumenTAL-3 study.

Johnson & Johnson (NYSE:JNJ) has filed a pre-packaged bankruptcy in Texas, claiming 83% of surveyed plaintiffs agree to the plan's terms. Attorneys representing ovarian cancer victims linked to J&J's talc products vow to seek dismissal, calling it a fraudulent effort to manipulate the bankruptcy process. They argue that the proposed compensation is inadequate, with average medical costs for treating ovarian cancer exceeding $220,000 and lost wages averaging over $230,000.

Lawyers question the integrity of the voting process and cite the recent U.S. Supreme Court ruling in Harrington v. Purdue Pharma as a reason why J&J's plan should not succeed. They also criticize J&J's choice of filing in Texas as forum shopping. Previous bankruptcy attempts by J&J were found to be in bad faith by courts in New Jersey and the Third Circuit.

Johnson & Johnson announced that its subsidiary, Red River Talc , has filed a voluntary prepackaged Chapter 11 bankruptcy case to resolve all current and future ovarian cancer claims related to cosmetic talc litigation in the United States. The proposed bankruptcy plan has received support from approximately 83% of current claimants, exceeding the 75% approval threshold required by the U.S. Bankruptcy Code.

Red River has increased its settlement commitment by $1.75 billion to approximately $8 billion. The plan represents a present value of about $8 billion to be paid over 25 years, totaling approximately $10 billion nominal. This settlement is one of the largest ever reached in a mass tort bankruptcy case.

The company maintains that none of the talc-related claims have merit, citing rejections by independent experts and regulatory bodies. The plan would resolve 99.75% of all pending talc lawsuits against Johnson & Johnson and its affiliates in the United States.

Johnson & Johnson (NYSE: JNJ) announced FDA approval of RYBREVANT® (amivantamab-vmjw) in combination with standard chemotherapy for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations, whose disease progressed after EGFR tyrosine kinase inhibitor treatment.

The approval is based on the Phase 3 MARIPOSA-2 study, which showed RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 52 percent compared to chemotherapy alone. The median progression-free survival was 6.3 months for the combination therapy versus 4.2 months for chemotherapy alone.

This marks the third new indication for RYBREVANT® this year, bringing potential new standards of care to nearly 30,000 patients diagnosed with EGFR-mutated NSCLC in the United States annually.

Johnson & Johnson (NYSE: JNJ) announced interim data from the Phase 2 SunRISe-4 study, showing that neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) nearly doubled the pathological complete response (pCR) rate compared to CET alone in patients with muscle-invasive bladder cancer (MIBC). Key findings include:

- 42% pCR rate for TAR-200 plus CET vs. 23% for CET alone
- 60% pathological overall response rate for combination vs. 36% for CET alone
- In patients with organ-confined disease, 48% pCR rate for combination vs. 23% for CET alone
- 68% of patients with organ-confined disease were downstaged at radical cystectomy

The treatment showed a manageable safety profile, with mostly Grade 1-2 adverse events. These results suggest TAR-200 plus cetrelimab could potentially alter bladder cancer treatment approaches.

Johnson & Johnson (NYSE: JNJ) announced promising results from the Phase 2b SunRISe-1 study of TAR-200 for treating high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Key findings include:

- 83.5% complete response rate in the pivotal Cohort 2 (TAR-200 monotherapy)
- 82% of patients maintained response after a median 9-month follow-up
- Estimated 12-month complete response rate of 57.4%
- Low discontinuation rates due to treatment-resistant adverse events (6% in Cohort 2)

The study also evaluated TAR-200 plus cetrelimab (Cohort 1) and cetrelimab monotherapy (Cohort 3), but results favor TAR-200 monotherapy. These findings support TAR-200's potential as a novel treatment for patients unresponsive to BCG immunotherapy, offering an alternative to radical cystectomy.

Johnson & Johnson (NYSE:JNJ) announced promising results from the Phase 1b/2 OrigAMI-1 study at ESMO 2024. RYBREVANT® (amivantamab-vmjw) combined with chemotherapy showed a 49% overall response rate in RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients who hadn't received anti-EGFR therapy. Key findings include:

- Median duration of response: 7.4 months
- Median progression-free survival: 7.5 months
- Disease control rate: 88%
- 21% of patients proceeded to curative-intent surgery

The safety profile was manageable, with no new safety signals observed. These results suggest RYBREVANT®'s potential beyond lung cancer, particularly in EGFR inhibitor-naïve mCRC patients. Pivotal Phase 3 trials for RYBREVANT®-based regimens in colorectal cancer are planned.