Johnson & Johnson ( JNJ Quick Quote JNJ - Free Report) announced that it is stopping a phase III study called MACiTEPH, evaluating its pulmonary arterial hypertension (PAH) drug, macitentan (75 mg) in patients with chronic thromboembolic pulmonary hypertension (CTEPH).
CTEPH is a rare form of pulmonary hypertension that occurs when there is abnormally high pressure in the lungs’ small blood vessels.
The decision to end the CTEPH study, due to futility, was made at the recommendation of the study’s independent data monitoring committee following a pre-planned interim analysis.
J&J markets macitentan as Opsumit to treat PAH, WHO Group 1. PAH means there is high blood pressure in the arteries of the lungs.
J&J entered the PAH drugs category with the 2017 acquisition of Actelion. J&J’s another key PAH drug is Uptravi. J&J is also conducting a phase III study (UNISUS) to demonstrate the superiority of a 75 mg dose of Opsumit over the currently marketed 10 mg dose.
In addition, J&J’s new drug application seeking approval for the single tablet combination therapy of macitentan and tadalafil for long-term treatment of PAH is under review in the United States and EU. The regulatory applications were based on positive data from J&J’s phase III A DUE study.
J&J’s stock has declined 10.6% so far this year against an increase of 6.5% for the
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In a separate press release, J&J announced positive top-line data from a phase III study evaluating regimens based on its new cancer drug, Rybrevant, in the broader EGFR-mutated non-small cell lung cancer (NSCLC) population,
The study, called MARIPOSA-2, evaluated Rybrevant plus chemotherapy with and without lazertinib versus chemotherapy alone in patients with EGFR-mutated NSCLC after disease progression on osimertinib. The study met its dual primary endpoint, resulting in statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy alone in both experimental treatment arms.
Rybrevant is presently approved for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.
Another phase III study called PAPILLON has earlier demonstrated the potential of Rybrevant to improve outcomes in patients with EGFR-mutated NSCLC. PAPILLON evaluated Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
Last month, J&J filed a supplemental biologics license application (sBLA) to the FDA seeking approval of Rybrevant in combination with chemotherapy for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations based on data from the PAPILLON study.
Rybrevant is being evaluated in multiple clinical studies in NSCLC, including the pivotal phase III study called MARIPOSA, which is evaluating Rybrevant and lazertinib for first-line EGFR-mutated NSCLC.
Zacks Rank & Stocks to Consider
J&J currently has a Zacks Rank #4 (Sell).
Some better-ranked biotech companies are
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