The Targeted Pulse: New Approvals Are Advancing the Field, and the MARIPOSA Trial Continues to Deliver

Durvalumab Regimen Scores An Approval for MIBC

Durvalumab (Imfinzi) in combination with chemotherapy followed by single-agent durvalumab has received FDA approval for the treatment of muscle-invasive bladder cancer after radical cystectomy. This approval is supported by data from the phase 3 NIAGARA trial (NCT03732677), which compared the regimen to 4 cycles of gemcitabine/cisplatin alone prior to cystectomy, with no further treatment after surgery.

In the trial, 1063 patients were randomly assigned 1:1 to receive either of the 2 regimens. In the experimental arm, patients received 1500 mg of intravenous durvalumab every 3 weeks, combined with gemcitabine/cisplatin for 4 cycles. This was followed by single agent durvalumab every 4 weeks post-radical cystectomy for 8 cycles. Investigators reported that the experimental regimen was well tolerated, with no safety signals observed. For more details, access the full article here.

Leronlimab Receives Clearence for Phase 2 Trial in mCRC

An open-label, randomized, 2-arm, multicenter, phase 2 study (NCT06699835) evaluating leronlimab in patients with relapsed/refractory microsatellite stable (MSS) metastatic colorectal cancer (mCRC) has received FDA clearance.

The trial will assess the overall response rate (ORR)––which is the primary end point––overall survival (OS), safety, and tolerability of leronlimab when combined with trifluridine and tipiracil (TAS-102; Lonsurf) and bevacizumab (Avastin) in patients with CCR5-positive, MSS relapsed/refractory mCRC. The treatment regimens include leronlimab at a dose of 350 mg in combination with TAS-102 and bevacizumab or a 700 mg dose of leronlimab in combination with TAS-102 and bevacizumab.

Secondary end points include duration of response (DOR) and treatment-emergent adverse events that occur on or after the first treatment. For more details and enrollment information, access the full article here

Amivantamab/Lazertinib Continues to Show OS Benefit in EGFR+ NSCLC

In the first line, amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) showed improved OS in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. These findings come from the phase 3 MARIPOSA study (NCT04487080), which evaluated the combination against osimertinib (Tagrisso). The data also demonstrated benefit for several secondary end points, including intracranial progression-free survival, intracranial DOR, and intracranial ORR.

“The MARIPOSA trial is demonstrating a novel survival benefit with amivantamab plus lazertinib that is a new standard of care for the first-line treatment of patients with EGFR-mutated NSCLC,” Nicolas Girard, MD, PhD, a thoracic oncologist at the Institut Curie in Paris, France, told Targeted Oncology^TM in an interview. For more details, access the full article here.

Dr Girard Provides Insight on MARIPOSA Trial for EGFR+ NSCLC

In this video, Nicolas Girard, MD, PhD, a thoracic oncologist at the Institut Curie in Paris, France, provides deeper insight into the positive findings from the MARIPOSA study. As mentioned, the MARIPOSA study evaluated amivantamab-vmjw plus lazertinib vs osimertinib as a first-line treatment for patients with EGFR-mutant advanced NSCLC.

Girard explains that the anticipated OS findings were finally presented at the 2025 European Lung Cancer Congress and offers a key takeaway on the presented data. “In line with what was reported historically with amivantamab plus lazertinib, the median is not reached already, but the lower boundary of the confidence interval is about 43 months, so we expect this 12-month difference,” Girard explains. For further insights, access the video here.

Cabozantinib Takes Home Approval for Advanced Neuroendocrine Tumors

Cabozantinib (Cabometyx) has received FDA approval for the treatment of resectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). This approval extends to both adult patients and pediatric patients 12 years or older. The approval is supported by findings from the phase 3 CABINET trial (NCT03375320), which was closed early due to the benefits observed in the interim evaluation.

In the multicenter, double-blind trial, 203 patients with epNETs and 95 with pNETs were randomly assigned 2:1 into 2 separate cohorts to receive 60 mg cabozantinib or placebo daily.

The recommended dose for patients weighing 40 kg or more is 60 mg of cabozantinib given orally once daily. For those with a body weight of less than 40 kg the recommended dose is 40 mg orally once daily. Treatment should continue until disease progression or unacceptable toxicity. For further information, access the full article here.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

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