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Fam-trastuzumab deruxtecan in metastatic HER2-positive breast cancer (April 2022)

Although the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) has an established role in metastatic HER2-positive breast cancer, novel antibody drug conjugates such as fam-trastuzumab deruxtecan (T-DXd) are emerging. In a randomized trial in over 500 patients with HER2-positive metastatic breast cancer with progression on a trastuzumab- and taxane-containing regimen, median progression-free survival was 25 months for T-DXd and 7.2 months for T-DM1 [1]. The estimated 12-month overall survival (OS) rates were 94 percent with T-DXd and 86 percent for T-DM1; although the difference in OS was not statistically significant, results were immature. Given these data, we now consider T-DXd an appropriate option after progression on a trastuzumab- and taxane-containing regimen.

First-line therapy for high-risk, high-volume metastatic hormone-sensitive prostate cancer (April 2022)

Docetaxel plus androgen deprivation therapy (ADT) is a standard approach for initial treatment of patients with hormone-sensitive, high-risk, high-volume metastatic prostate cancer. Two trials now demonstrate an overall survival benefit from the addition of a second systemic agent to ADT plus docetaxel. In the ARASENS trial, the addition of darolutamide to ADT plus docetaxel improved overall survival and all secondary endpoints without worsening treatment-related toxicity in men with metastatic castration-sensitive prostate cancer (CSPC), and the benefits were similar in most subgroups [2]. In the PEACE-1 trial, the addition of abiraterone to ADT plus docetaxel also improved survival over ADT plus docetaxel alone in patients with de novo metastatic CSPC [3].

Induction chemotherapy regimens for advanced nasopharyngeal carcinoma (April 2022)

For patients with advanced nasopharyngeal carcinoma (NPC), induction chemotherapy (IC) followed by concurrent chemoradiation (CRT) is the standard of care, but studies directly comparing IC regimens are limited. In a phase III trial of IC with cisplatin plus paclitaxel and capecitabine (TPC) versus cisplatin plus fluorouracil in over 200 patients with locoregionally advanced NPC, TPC improved failure-free survival (84 versus 69 percent) and was well tolerated. Overall survival at three years was similar between groups (95 versus 89 percent) [4]. For patients with advanced NPC, while gemcitabine plus cisplatin continues to be our preferred IC regimen, we consider TPC to be one acceptable alternative option in this patient population.

Nivolumab plus relatlimab for advanced melanoma (April 2022)

For patients with metastatic melanoma, there is interest in identifying therapies that enhance efficacy and reduce toxicity. In a double-blind phase III trial of over 700 patients with treatment-naive advanced melanoma, nivolumab plus relatlimab, a human immunoglobulin G4 lymphocyte activation gene 3-blocking antibody, improved progression-free survival (median 10 versus 5 months) compared to single-agent nivolumab [5,6]. Although differences in three-year overall survival were not statistically significant (56 versus 48 percent, respectively), results were immature at a median follow-up of 19 months. Grade >=3 treatment-related adverse events occurred in 19 percent in the nivolumab-relatlimab group and 10 percent in the nivolumab group. Based on these data, the US Food and Drug Administration approved nivolumab-relatlimab for patients with unresectable or metastatic melanoma ages 12 years and older, and we consider it as one acceptable option in both BRAF wildtype and mutant disease [7].

1. Cortes J, Kim, S, Chung W. LBA1 - Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (Pts) with HER2+ metastatic breast cancer (mBC): Results of the randomized phase III DESTINY-Breast03 study. Ann Oncol. 2021;32S5:S1283.

2. Smith MR, Hussain M, Saad F, et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022;386(12):1132. Epub 2022 Feb 17.

3. Fizazi K, Foulon S, Carles J, et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel. Lancet. 2022.

4. Li WZ, Lv X, Hu D, et al. Effect of Induction Chemotherapy With Paclitaxel, Cisplatin, and Capecitabine vs Cisplatin and Fluorouracil on Failure-Free Survival for Patients With Stage IVA to IVB Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022.

5. Tawbi HA, Schadendorf D, Lipson EJ. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022;386(1):24.

6. Long GV, Hodi S, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in previously untreated metastatic or unresectable melanoma: Overall survival and response rates from RELATIVITY-047 (CA224-047). J Clin Oncol. 2022;40;36S.

7. Nivolumab-relatlimab: US Food and Drug Administration Label and Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf (Accessed on March 21, 2022).

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