Amivantamab/Lazertinib Scores Factors in NSCLC, Nivolumab Boosts Remedy for Uterine and Ovarian Cancers, and Extra


Frontline Amivantamab/Lazertinib Trumps Osimertinib in EGFR-Optimistic NSCLC

The mix of amivantamab-vmjw (Rybrevant) and lazertinib (Leclaza) elicited larger progression-free survival (PFS) and length of response (DOR) within the frontline compared with osimertinib (Tagrisso) for sufferers with EGFR-mutated non–small cell lung most cancers (NSCLC). These findings come from the section 3, worldwide, randomized MARIPOSA trial (NCT04487080), wherein investigators randomly assigned sufferers 2:2:1 to obtain both amivantamab-lazertinib, osimertinib alone, or lazertinib alone. Sadly, there have been some sufferers from the amivantamab/lazertinib and osimertinib arms that discontinued remedy due to treatment-related adversarial occasions (AEs).

“With the addition of amivantamab, which is a bispecific EGFR/MET antibody, we anticipated and did have extra AEs. In fact, the AEs did should be managed. The everyday AEs are rash, cutaneous reactions, and immune-related AEs. Probably the most regarding factor over time are usually not the immune-related reactions, as a result of that’s usually [observed with] the primary dose,” Alexander Spira, MD, PhD, director of the Virginia Most cancers Specialists Analysis Institute and investigator on the MARIPOSA trial, advised Focused OncologyTM in an interview.

Breakthroughs in Lung Most cancers Remedy Offered at ASCO Defined

On this article, Aakash Desai, MD, MPH, explains the present breakthroughs offered on the 2024 American Society of Medical Oncology (ASCO) Annual Assembly concerning lung most cancers remedy. Desai highlights knowledge from the PACIFIC (NCT02125461), LAURA (NCT03521154), and CROWN (NCT03052608) trials, wherein focused therapies for sufferers with oncogene-driven NSCLC had been used. He additionally explains the promising knowledge from the ADRIATIC research (NCT03703297) for small cell lung most cancers (SCLC) and the wants left unanswered from the EVOKE-01 research (NCT05089734) for these with refractory or relapsed illness after immunotherapy or chemotherapy.

“We additionally noticed median total survival [OS] profit with durvalumab at 55 months vs 33 with placebo. I believe this is a crucial advance, particularly for [SCLC], which is a really difficult-to-treat illness and an aggressive illness. For these sufferers with limited-stage SCLC, the choice of incorporating immunotherapy and the outcomes and efficacy that we see is thrilling, and I undoubtedly will use it within the clinic as soon as it’s accredited,” Desai stated.Desai is thoracic and section 1 medical oncologist and assistant professor on the O’Neal Most cancers Middle on the College of Alabama, Birmingham.

Exploring Immunotherapy Mixtures Based mostly on PD-L1 Expression in NSCLC

Within the first installment of this 2-part collection, John V. Heymach, MD, PhD, discusses the usage of immunotherapy mixtures primarily based on PD-L1 expression in a 62-year-old affected person with NSCLC. Within the dialogue, he highlights knowledge from the KEYNOTE-407 (NCT02775435) and CheckMate 9LA (NCT03215706) trials and offers invaluable insights concerning FDA drug approvals and the way he administers sure mixtures for particular affected person populations.

“When your affected person has destructive PD-L1 expression, the DOR to PD-1 inhibitor monotherapy tends to be a lot shorter. That’s a part of the rationale I are likely to go in direction of twin immunotherapy sooner or later in sufferers with the PD-L1 expression lower than 1%, however you actually may use monotherapy,” Heymach stated within the dialogue for the Case-Based mostly Roundtable® occasion. Heymach is professor within the Division of Most cancers Biology and David Bruton, Jr Chair in Most cancers Analysis Chair within the Division of Thoracic/Head and Neck Medical Oncology Division of Most cancers Drugs at The College of Texas MD Anderson Most cancers Middle in Houston, Texas.

Nivolumab Delivers Improved PFS and ORR in Uterine and Ovarian Cancers

Nivolumab (Opdivo) elicited promising PFS and total response charges in a single arm, section 2 trial (NCT03241745) for these with mismatch restore deficiency (dMMR) in uterine or ovarian cancers, assembly its coprimary finish factors. Remedy choices with PD-1 inhibitors for dMMR gynecologic cancers are restricted, which led to the analysis of nivolumab’s security and efficacy for this affected person demographic.

Within the research, nivolumab was given as soon as each 4 weeks at a dose of 480 mg and remedy continued till both illness development or improvement of unacceptable toxicity. Enrolled sufferers had a histologically confirmed prognosis of metastatic or recurrent uterine most cancers, together with endometrial carcinoma, carcinosarcoma, clear cell carcinoma, leiomyosarcoma, undifferentiated sarcoma, and high-grade endometrial stromal sarcoma. Secondary finish factors had been OS, illness management fee (DCR), DOR, and security. As well as, there have been exploratory finish factors that evaluated biomarkers and molecular correlates of response.

Approval Request Submitted for Curium’s Lutetium Lu 177 SSTR+ GEP-NETs

A 505(b)(2) request for FDA approval has been submitted for Curium’s formulation of lutetium Lu 177 (Lutathera) dotatate injection for the remedy of somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).The agent has demonstrated improved PFS compared with high-dose octreotide within the NETTER-1 trial (NCT01578239). The Novartis firm, Superior Accelerator Purposes, gained approval for the agent in January 2018 for the remedy of grownup sufferers with SSTR-positive GEP-NETs, together with foregut, midgut, and hindgut NETs.

“Curium’s 505(b)(2) NDA for lutetium Lu 177 dotatate injection marks one other vital milestone for Curium in its evolution to convey new instruments for sufferers and well being care suppliers to each diagnose and now doubtlessly deal with illness,” stated Michael Patterson, chief govt officer of Curium North America, in a press launch. “Nuclear medicine-based most cancers therapies should proceed to be extra extensively and reliably accessible for sufferers and their caregivers.”

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