Deciphera Pharmaceuticals $DCPH stock formed a descending triangle breakout on January 4, 2023. The stock is in a technical uptrend.
Deciphera price target raised at Barclays
Following the company’s announcement of preliminary Q4 revenues and fresh data analysis pointing to a potential market opportunity in second-line gastrointestinal stromal tumor patients on January 4, 2023, Barclays analyst Peter Lawson raised the price target on Deciphera from $8 to $9 while maintaining an Underweight rating on the shares. For the target bump, the analyst points to a potential GIST opportunity.
Deciphera upgraded to Buy at Guggenheim
Following the company’s business update and recently disclosed plans to launch the Phase III INSIGHT study evaluating Qinlock in second line gastrointestinal stromal tumors, Guggenheim analyst Michael Schmidt upgraded $DCPH stock to Buy from Neutral with a $22 price target on January 4, 2023. The analyst’s confidence in Qinlock’s growth prospects has increased. According to Schmidt’s research note to investors, the study in second line GIST presents a potential $175–200 million US label expansion opportunity for Qinlock.
Deciphera announces results from ctDNA analysis from Intrigue Phase 3 trial
Deciphera Pharmaceuticals released the results of an exploratory analysis of data from the INTRIGUE Phase 3 clinical study of QINLOCK using circulating tumor DNA from a subgroup of patients with gastrointestinal stromal tumors who had previously received imatinib and who only have mutations in KIT exons 11 and 17/18 on January 3, 2023.
“We are extremely pleased by the exploratory analysis showing that QINLOCK, already the standard of care for fourth-line GIST patients, provided substantial clinical benefit to this subgroup of second-line patients compared to sunitinib. We look forward to presenting additional data from the overall ctDNA analysis at a medical meeting later this month,” said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. “Given the strength of these results, and after consultation with the FDA, we plan to initiate our INSIGHT pivotal Phase 3 study in the second half of 2023. If positive, we believe this trial will transform the standard of care for this subgroup of second-line GIST patients based on their mutational profile.”
Evaluating QINLOCK’s anti-tumor efficacy in relation to the primary and secondary mutation status of KIT at baseline in GIST patients who had previously received imatinib treatment was one exploratory goal of the INTRIGUE Phase 3 study. Guardant360, a liquid biopsy assay for 74-gene ctDNA next-generation sequencing, was used to examine baseline peripheral whole blood. Baseline ctDNA was examined in 362 of the 453 patients in the total intent-to-treat population (ITT) for whom evaluable samples were available. KIT mutations were found in 213 patients and ctDNA was found in 280 samples. KIT exon 11 and exon 9 primary mutations were found in 157 and 36 patients, respectively. In 89 patients, exons 17/18 of KIT were found to have common resistance mutations, and in 81 patients, exons 13/14. 52 patients had mutations in exon 17/18 alone, 41 patients had mutations in exon 13/14 alone, and 22 patients had mutations in both exon 13/14 and exon 17/18 in patients with a KIT exon 11 primary mutation. QINLOCK significantly outperformed sunitinib in terms of progression-free survival (PFS), objective response rate (ORR), and overall survival (OS) in patients with mutations in KIT exon 11 and exon 17/18. According to the primary analysis of the INTRIGUE study based on tumor data used for randomization, the efficacy results in patients with detectable ctDNA in KIT exon 11 and in the ITT populations were consistent with each other. The safety profiles for the subgroups matched the results of the initial analysis.