Kristi Rosa

The FDA has granted breakthrough therapy designation to TAR-200 for use in the treatment of patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle invasive bladder cancer who are not candidates for or opted not to receive radical cystectomy.

The safety and efficacy data observed with the administration of 5 or more cycles of induction platinum/etoposide and concurrent durvalumab in patients with extensive-stage small cell lung cancer enrolled in the phase 3b LUMINANCE study aligned with outcomes reported in the phase 3 CASPIAN trial.

The FDA has granted fast track and breakthrough therapy designations to cretostimogene grenadenorepvec for use as a potential therapeutic option in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

A coformulation of vibostolimab and pembrolizumab with or without docetaxel failed to result in a statistically significant improvement in progression-free survival compared with docetaxel alone in patients with metastatic non­–small cell lung cancer.

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.

The FDA has granted fast track designation to aglatimagene besadenovec plus valacyclovir for use as a potential therapeutic option in patients with pancreatic ductal adenocarcinoma.

The National Medical Products Administration of China has approved sugemalimab paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Maurie Markman, MD, discusses current challenges faced with developing robust decision support tools for oncologists and projects additional research efforts dedicated to finding a way to leverage CAR T-cell therapies in solid tumors to improve patient outcomes.

The European Commission has approved new indications for pembrolizumab in combination with chemotherapy in select patients with gastric or gastroesophageal adenocarcinoma and select patients with biliary tract cancer.

Treatment with 177Lu-PNT2002 resulted in a significant improvement in radiographic progression-free survival vs abiraterone acetate or enzalutamide in patients with metastatic castration-resistant prostate cancer whose disease had progressed on an androgen receptor pathway inhibitor.

Dostarlimab plus carboplatin and paclitaxel, followed by maintenance dostarlimab and niraparib, significantly improved PFS vs placebo plus chemotherapy followed by placebo in patients with primary advanced or recurrent endometrial cancer, according to data from the phase 3 RUBY trial.

The combination regimen comprised of acalabrutinib, venetoclax, and obinutuzumab proved to be safe and feasible and to elicit responses in patients with high-risk, relapsed or refractory mantle cell lymphoma.

Relmacabtagene autoleucel continued to induce responses with acceptable tolerability in Chinese patients with relapsed or refractory mantle cell lymphoma.

The oral selective PIM1 kinase inhibitor TP-3654 appeared to be well tolerated and to show early signals of spleen volume reduction, symptom improvement, and correlating cytokine reductions in patients with relapsed or refractory myelofibrosis, according to preliminary data.

The FDA has issued a complete response letter to the biologic license application seeking the approval of cosibelimab for use in patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or radiation.

The tumor-infiltrating lymphocyte cell therapy OBX-115 produced responses with no dose-limiting toxicities in heavily pretreated patients with advanced or metastatic melanoma whose who had progressed on anti–PD-1 and anti–CTLA-4 therapy with disease that was primary-resistant to immune checkpoint inhibitor therapy.

The FDA has granted fast track designation to naporafenib plus trametinib for use as a potential therapeutic option in adult patients with unresectable or metastatic melanoma with an NRAS mutation who progressed on or are intolerant to a PD-1/PD-L1–based regimen.

The combination of RP1 and cemiplimab provided a numerical, but not statistically significant, improvement in response rates vs cemiplimab alone in patients with locally advanced or metastatic cutaneous squamous cell carcinoma, missing the primary end points of the phase 2 CERPASS trial.

The European Commission has granted marketing authorization to dostarlimab paired with carboplatin and paclitaxel in adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are eligible to receive systemic treatment.

Anitocabtagene autoleucel showcased early efficacy with acceptable toxicity in patients with relapsed and/or refractory multiple myeloma—even in those with high-risk features.

Axatilimab induced rapid and durable responses with an acceptable toxicity profile at all doses analyzed with highest efficacy observed at the 0.3-mg/kg dose in patients with recurrent or refractory chronic graft-vs-host disease.

Pirtobrutinib continued to showcase clinically meaningful efficacy in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a covalent BTK inhibitor.

The addition of atezolizumab to neoadjuvant trastuzumab plus pertuzumab (HP) and chemotherapy led to a numerical, but not statistically significant, increase in pathologic complete response vs HP/chemotherapy alone in patients with HER2-positive operable breast cancer.

The phase 3 KEYLYNK-008 trial evaluating pembrolizumab plus olaparib in patients with metastatic squamous non–small cell lung cancer will be discontinued for futility, according to an announcement from Merck.

The addition of inavolisib to palbociclib and fulvestrant improved progression-free survival vs palbociclib and fulvestrant alone in select patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.

The addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab plus endocrine therapy improved pathologic complete responses in key subsets of patients with early-stage, high-risk, estrogen receptor–positive/HER2-negative breast cancer enrolled in the phase 3 KEYNOTE-756 trial.

The FDA has approved iptacopan (Fabhalta) for use in adult patients with paroxysmal nocturnal hemoglobinuria.

The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received 1 to 3 lines of systemic treatment to full approval.

The FDA has granted priority review to a supplemental biologics license application seeking the approval of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma.

The FDA has granted orphan drug designation to LP-284 for use in the treatment of patients with high-grade B-cell lymphoma harboring MYC and BCL2 rearrangements.