Shares of NuCana plc NCNA skyrocketed 150.8% on Monday after the announcement of encouraging final data from the mid-stage study of its investigational candidate, NUC-7738, in combination with Merck’s MRK blockbuster oncology drug, Keytruda (pembrolizumab), to treat metastatic melanoma. The melanoma patient population included those who were refractory to or had relapsed on prior PD-1 inhibitor therapy.
The results were presented at the ESMO Congress held on Sept. 14, 2024, in Spain.
Per the data readout from the phase II NuTide:701 study, out of the 12 patients treated with the NUC-7738/Meck’s Keytruda combo regimen, nine (75%) achieved disease control, including two patients who achieved partial responses.
A patient who had previously undergone two rounds of PD-1 inhibitor therapy and experienced disease progression within two months after treatment with Bristol Myers’ BMY Yervoy (ipilimumab) and Opdivo (nivolumab), achieved a 55% reduction in tumor size. Additionally, seven out of the 12 patients had a progression-free survival exceeding five months, which is unusually long for this group. Per NuCana, the median progression-free survival duration with the standard-of-care treatment for PD-1 inhibitor refractory and resistant melanoma patients is 2-3 months.
In the NuTide:701 study, the combination of NUC-7738 and Meck’s Keytruda also demonstrated a favorable safety profile.
NUC-7738 is a novel anti-cancer agent that disrupts RNA polyadenylation. Its unique mechanism of action allows the candidate to sensitize PD-1-resistant tumors to rechallenge with PD-1 inhibitors. Per the company, the data presented from tumor biopsies obtained before and after NUC-7738-based treatment demonstrated increases in genes related to antigen presentation and T-cell activation, which supports the hypothesis.
Year to date, shares of NuCana have lost 13.9% against the industry’s 0.5% growth.
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Bristol Myer’s immunotherapy drug, Opdivo, in combination with Yervoy, is indicated for the treatment of adult and pediatric patients of 12 years and older with unresectable or metastatic melanoma. Both drugs are individually approved for the melanoma indication. Bristol Myer is also currently conducting studies to further expand the combo’s label. Bristol Myer’s Opdivo is approved both as a monotherapy and in combination with Yervoy to treat several other cancer indications in many countries, including the United States and the EU.
Like Bristol Myers’ Opdivo, Merck’s Keytruda is also an anti-PD-1 therapy. It is currently marketed as the standard of care in the frontline treatment of metastatic non-small cell lung cancer patients. Merck’s Keytruda is approved for several types of cancer, accounting alone for 47% of the company’s pharmaceutical sales in 2023. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
Based on additional data on NUC-7738 obtained in other tumor types, NuCana believes that the unique mechanism of action of the candidate is not restricted to melanoma and that NUC-7738 could potentially sensitize other PD-1 inhibitor-resistant tumor types.
The company expects to share further development plans for NUC-7738 soon.
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Apart from NUC-7738, NuCana’s clinical pipeline has another investigational candidate, NUC-3373, which is currently being evaluated in combination with other agents in three separate early to mid-stage studies to treat colorectal cancer, lung cancer and advanced solid tumors.
Data readouts from all three studies are expected by the end of 2024.
NuCana currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Illumina, Inc. ILMN, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.84 to $3.62. The consensus estimate for 2025 earnings has improved from $3.22 to $4.43. Year to date, shares of ILMN have lost 7%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
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