In the realm of oncology, particularly in the fight against skin cancer, the past decade has witnessed remarkable progress. With a surge in research endeavors and the subsequent green lights from regulatory authorities, the landscape of patient care has significantly evolved. As we commemorate Skin Cancer Awareness Month, Dermatology Times embarks on a retrospective journey spanning the last ten years, delving into the pivotal milestones within the skin cancer drug pipeline.
November 2015: Cobimetinib Emerges
November 10, 2015, marked a pivotal moment as the FDA bestowed its approval upon Genentech’s Cotellic (cobimetinib). This approval, coupled with Zelboraf (vemurafenib), aimed to combat advanced melanoma bearing BRAF V600E or V600K mutations. The green light was backed by compelling data from the phase III coBRIM study, showcasing a substantial enhancement in both progression-free survival and overall survival compared to monotherapy with Zelboraf. Notably, patients under the combination therapy exhibited a median progression-free survival of 12.3 months, a notable leap from the 7.2 months observed with Zelboraf alone.
June 2018: Binimetinib’s Triumph
Fast forward to June 27, 2018, as the FDA extended its approval to the encorafenib (Braftovi) and binimetinib (Mektovi) duo, specifically targeting patients grappling with unresectable or metastatic melanoma carrying BRAF V600E or V600K mutations. This regulatory nod, stemming from the encouraging outcomes of the COLUMBUS trial involving 577 patients, showcased a noteworthy median progression-free survival of 14.9 months under the combination therapy, in stark contrast to the 7.3 months observed with vemurafenib monotherapy. Additionally, the approval ushered in the validation of the THxID BRAF Kit as a companion diagnostic tool for these therapeutic interventions.
September 2018: Cemiplimab-rwlc’s Inception
Come September 28, 2018, and the FDA extended its approval to cemiplimab-rwlc (Libtayo), a beacon of hope for patients combating metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) devoid of curative surgical or radiation options. This green light was predicated upon the robust and enduring objective response rates observed in two pivotal clinical trials, R2810-ONC-1423 and R2810-ONC-1540. These trials unveiled an overall response rate of 47%, with a subset of patients achieving complete or partial responses. Noteworthy was the durability of responses, with a median response duration yet to be reached and 61% of responses persisting for six months or beyond.
December 2021: Pembrolizumab’s Crusade
December 3, 2021, etched another milestone as the FDA sanctioned pembrolizumab (Keytruda) for the adjuvant treatment of adults and adolescents (aged 12 years and above) grappling with stage IIB or IIC melanoma post-complete resection. Anchored on the pivotal KEYNOTE-716 trial, this regulatory seal was derived from a randomized, double-blind, placebo-controlled study, unraveling a substantial uptick in recurrence-free survival (RFS) amongst participants administered pembrolizumab, with a notable hazard ratio of 0.65.
October 2023: Nivolumab’s Dawn
In a significant stride towards combating stage IIB or IIC melanoma, October 13, 2023, bore witness to the FDA’s approval of nivolumab (Opdivo) from Bristol Myers Squibb for adjuvant treatment post-complete resection. This landmark decision stemmed from the compelling findings of the phase 3 CheckMate -76K trial, underscoring nivolumab’s prowess in enhancing recurrence-free survival (RFS) vis-à-vis placebo. Of paramount importance was the consistent safety profile, mirroring previous studies.
January 2024: DermaSensor’s Proclamation
The advent of January 2024 heralded the FDA’s clearance of DermaSensor, a handheld marvel engineered for the detection of skin cancers encompassing melanoma, basal cell carcinoma, and squamous cell carcinoma. Leveraging AI prowess, this device, tailored for utilization by primary care physicians, harnesses elastic scattering spectroscopy to scrutinize suspicious skin lesions. A multicenter study unveiled its commendable sensitivity of 95.5% and specificity of 32.5%, underpinning its diagnostic efficacy.
February 2024: Lifileucel’s Expedition
In February 2024, Iovance Biotherapeutics unfurled the accelerated FDA approval of lifileucel (Amtagvi), charting new territories in the management of adult patients contending with unresectable or metastatic melanoma, having previously undergone treatment with a PD-1 blocking antibody. The green light, anchored on the robust objective response rate and duration of response culled from the C-144-01 clinical trial, spotlighted a 31.5% objective response rate alongside a median duration of response yet to be ascertained at an 18.6-month follow-up. Noteworthy was the sustenance of responses, with 43.5% persisting beyond the 12-month threshold in the trial cohort.In essence, the chronological narrative encapsulating these regulatory endorsements underscores a decade characterized by relentless strides towards ameliorating the landscape of skin cancer care. As we forge ahead, these milestones serve as beacons of hope, illuminating the path towards enhanced therapeutic outcomes and improved patient prognosis.
