Today, a brief rundown of news involving Roivant and AstraZeneca, as well as updates from Bristol Myers Squibb, Pharvaris and Inhibrx that you may have missed.
Roivant said Tuesday a would-be treatment for a particular kind of high blood pressure associated with lung inflammation met all of its main and secondary objectives in a Phase 2 trial. Roivant’s medication, “mosliciguat,” reduced by 56% a measure of how difficult it is for blood to flow through the lungs of people with pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Roivant claimed that result was the “highest ever reported” in a randomized pulmonary hypertension trial and has already begun a Phase 3 study. The “exceptional” results, along with plans to develop mosliciguat in other conditions, could yield a drug with more than $10 billion in yearly sales, wrote Leerink Partners analyst David Risinger. Roivant shares surged 20%.
AstraZeneca has bounced back to secure a U.S. clearance for its breast cancer pill Etcamah. In April, a Food and Drug Administration advisory committee voted against that therapy, finding the evidence supporting AstraZeneca’s application inconclusive. The FDA delayed a decision afterwards. On Friday, though, the agency ultimately granted an accelerated clearance to Etcamah in first-line, HR-positive, HER2-negative breast cancer. That approval endorses use of Etcamah once a so-called ESR1 mutation is detected with an FDA-authorized test, a first-of-its-kind treatment approach. Physicians polled by Leerink Partners have noted that AstraZeneca’s study didn’t clearly prove the benefits of that strategy compared to simply treating patients after their disease progresses. That issue “could impact the commercial opportunity,” wrote analyst Andrew Berens on Saturday. A bigger payoff could come if another ongoing study in first-line disease is successful, he added.
A new kind of cancer cell therapy from Bristol Myers Squibb has come through in a mid-stage trial, the company announced Tuesday. Dubbed arlocabtagene autoleucel or arlo-cel, the therapy is a CAR-T treatment directed at GPRC5D, a cell surface protein that’s overexpressed on diseased cells in multiple myeloma. Bristol Myers didn’t provide specific details. But it said arlo-cel demonstrated a “statistically significant and clinically meaningful” response rate in people whose multiple myeloma had progressed following at least four treatment lines — among them drugs aimed at BCMA, a more established multiple myeloma target.
An experimental, once-daily pill from Pharvaris helped reduce the rate of swelling attacks by 83% in a Phase 3 study in people with the rare genetic disorder hereditary angioedema, or HAE. The result announced Tuesday positions Pharvaris to seek approval of the therapy, deucrictibant, in the first half of 2027. Pharvaris claimed its trial was the first Phase 3 study that evaluated a preventive therapy against all three forms of HAE. Should it win a regulatory clearance, the treatment will battle against multiple other oral and injectable therapies for market share.
A combination of an immunotherapy from Inhibrx Biosciences and Merck & Co.’s Keytruda outperformed Keytruda alone in a mid-stage trial in head and neck cancer. According to Inhibrx, treatment with the INBRX-106 and Keytruda regimen was associated with a roughly 48% response rate in people with recurrent head and neck squamous cell carcinoma, versus around 27% for those who got Keytruda alone. Around 72% of INBRX-106 recipients were progression-free after six months, compared to nearly 43% of those in the control group. Inhibrx is expanding the trial to include 50 more patients with HPV-positive tumors, a subgroup where the drug’s effects appear strongest. The results “exceeded expectations,” wrote Stifel analyst Dara Azar. Still, shares fell by about 7%.
