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Novel Therapies Show Promise in Melanoma, Breast, and Prostate Cancers

10 months ago2 min read

Key Insights

  • Fianlimab plus cemiplimab demonstrates durable efficacy and a better-tolerated safety profile compared to ipilimumab and nivolumab in advanced melanoma, showing promise in ongoing adjuvant and frontline metastatic studies.

  • Inavolisib, combined with palbociclib and fulvestrant, receives FDA approval for HR+, HER2–, PIK3CA-mutated breast cancer, uniquely targeting and degrading the PI3K target to prevent cellular adaptation.

  • Talazoparib plus enzalutamide shows meaningful overall survival improvement in metastatic castration-resistant prostate cancer, offering hope for patients with limited effective treatment options.

The landscape of cancer treatment is evolving with the emergence of novel therapies and combinations that are showing promise across various cancer types. Recent data and approvals highlight advancements in melanoma, breast, and prostate cancers, offering new hope for patients and reshaping treatment paradigms.

Melanoma: Enhanced Efficacy with Novel Combination

Long-term follow-up data from a phase 1 study (NCT03005782) of fianlimab (an anti–LAG-3 agent) in combination with cemiplimab (Libtayo; an anti–PD-1 agent) in advanced melanoma continues to demonstrate promising efficacy and safety. Meredith McKean, MD, MPH, director of melanoma and skin cancer research at Sarah Cannon Research Institute, noted the excitement surrounding this regimen, stating that the objective response rate is doubled compared to anti–PD-1 therapy alone, with a safety profile better tolerated than ipilimumab (Yervoy) and nivolumab (Opdivo). Additional studies are ongoing in adjuvant and frontline metastatic settings to further explore the potential of this combination.

Breast Cancer: Targeting PI3K Mutations

Inavolisib (Itovebi), combined with palbociclib (Ibrance) and fulvestrant, has gained FDA approval for hormone receptor-positive (HR+), HER2-negative (HER2–), PIK3CA-mutated breast cancer. The approval was based on the phase 3 INAVO120 study (NCT04191499). Dejan Juric, MD, lead investigator of INAVO120, highlighted the unique mechanism of action of inavolisib, explaining that it not only inhibits the PI3K target but also promotes its degradation, preventing cells from adapting and reactivating the same target.

Prostate Cancer: Improving Survival in Advanced Stages

Talazoparib (Talzenna) plus enzalutamide (Xtandi) has demonstrated a meaningful overall survival improvement in patients with metastatic castration-resistant prostate cancer (mCRPC), including those with homologous recombination repair (HRR) gene mutations. The phase 3 double-blind TALAPRO-2 study (NCT03395197) evaluated the combination against placebo. Neeraj Agarwal, MD, FASCO, professor at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2, stated that these results indicate potentially practice-changing efficacy for talazoparib in combination with enzalutamide for patients with mCRPC, offering much-needed hope for patients with this advanced and aggressive stage of the disease.
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