Davy James

Data from the Phase III EMERGE trial show treatment with Symbravo provided more rapid and sustained migraine relief with improved quality of life in patients who previously had an inadequate response to CGRP treatments.

Tremfya could become the first IL-23 inhibitor with fully subcutaneous induction and maintenance options in the treatment of moderately to severely active ulcerative colitis.

The first prespecified interim analysis of the Phase III AMPLIFY trial found that fixed-duration Calquence (acalabrutinib) plus venetoclax, with or without Gazyva (obinutuzumab), significantly improved progression-free survival compared to chemoimmunotherapy in fit patients with previously untreated chronic lymphocytic leukemia.

The final analysis of the Phase III CheckMate -816 trial confirmed a statistically significant overall survival benefit for patients with resectable non-small cell lung cancer treated with neoadjuvant Opdivo (nivolumab) plus chemotherapy.

Five-year data from the POETYK PSO long-term extension trial confirm the sustained efficacy and safety of Sotyktu (deucravacitinib) for moderate-to-severe plaque psoriasis, with patients maintaining high clinical response rates and no new safety concerns identified.

Updated data from the Phase III TALAPRO-2 trial show that the combination of Talzenna (talazoparib) and Xtandi (enzalutamide) significantly improves overall survival in patients with metastatic castration-resistant prostate cancer regardless of mutation status.

The Phase II eNRGy trial showed durable antitumor activity with zenocutuzumab (Bizengri) in patients with NRG1 fusion–positive cancers, particularly non-small cell lung cancer and pancreatic cancer.

Phase III EV-302/KEYNOTE-A39 trial confirms that the combination of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) provides sustained and significant overall survival and progression-free survival benefits compared to chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer.

Gazyva/Gazyvaro (obinutuzumab) was found to significantly improve complete renal response in lupus nephritis patients, reinforcing its potential as an effective treatment option while also allowing for a reduction in corticosteroid use.

In the ALEXANDRA/IMpassion030 trial, Tecentriq (atezolizumab) added to postoperative chemotherapy was not found to improve treatment outcomes for patients with high-risk early-stage triple-negative breast cancer.

Braftovi (encorafenib) plus Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) improved progression-free survival and overall survival compared to chemotherapy in patients with metastatic colorectal cancer with a BRAF V600E mutation.

The 12-month open-label extension of the PACIFIC trial demonstrated that bexicaserin significantly reduced seizure frequency in patients with developmental and epileptic encephalopathies while maintaining a favorable safety and tolerability profile.

The Phase III HYPERION trial was stopped early after strong positive interim results from the ZENITH trial demonstrated the efficacy of Winrevair (sotatercept-csrk) in treating pulmonary arterial hypertension, making it unethical to continue.

Abelacimab was found to significantly lower factor XI levels and bleeding events compared to rivaroxaban (Xarelto) in patients with atrial fibrillation at moderate-to-high risk for stroke.

The Phase III INAVO120 trial found that a combination of Itovebi (inavolisib) with Ibrance (palbociclib) and Faslodex (fulvestrant) significantly improved overall survival and progression-free survival in patients with PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant advanced or metastatic breast cancer.

Phase III CheckMate -8HW trial shows the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improved progression-free survival and overall response rates in patients with microsatellite-instability–high or mismatch-repair–deficient metastatic colorectal cancer.

Keytruda (pembrolizumab) plus Lenvima (lenvatinib) and chemotherapy improved progression-free survival but did not achieve statistical significance for overall survival in patients with advanced HER2-negative gastroesophageal adenocarcinoma.

Phase III Vivacity-MG3 trial shows that nipocalimab, an investigational FcRn blocker, significantly the improves symptoms of generalized myasthenia gravis with a manageable safety profile.

Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

Phase III HELIOS-B trial found that Amvuttra (vutrisiran) also preserved functional capacity and quality of life in patients with transthyretin amyloidosis with cardiomyopathy.

Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability profile, further establishing its efficacy in obesity treatment.

An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.

Pilot trial shows that a user-friendly electronic patient-reported outcome (ePRO) monitoring system significantly improves patient-centered cardiovascular care by enhancing patient-physician communication, increasing clarity in treatment explanations, and empowering patients with better knowledge of their conditions.

Results from the TROPION-Lung05 and TROPION-Lung01 clinical trials show the promise of datopotamab deruxtecan, a novel TROP2-directed antibody-drug conjugate, for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

Phase III IRAKLIA trial shows that subcutaneous Sarclisa delivered via an on-body delivery system is as effective and safe as intravenous administration in treating relapsed or refractory multiple myeloma.

A Phase Ib/II dose escalation and expansion trial shows promising antitumor activity and durable responses with Talvey (talquetamab) plus Tecvayli (teclistamab) in the treatment of relapsed or refractory multiple myeloma, but a higher incidence of grade 3 or 4 infections.

Study finds the typical cost of clinical research for developing new drugs is lower than previously estimated, with median costs providing a more accurate reflection than mean costs.

Results from the Phase III MARIPOSA trial demonstrated the combination of Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) significantly improves overall survival compared to the current standard of care, Tagrisso (osimertinib), for patients with EGFR-mutated advanced or metastatic non-small cell lung cancer.

Study finds that addressing racial disparities in lupus clinical trials requires targeted education, increased diversity among trial staff, culturally sensitive recruitment strategies, and addressing social determinants of health to improve Black patient participation.