On September 17, 2020 Cullinan Pearl, a Cullinan Oncology company, reported that an abstract detailing the ongoing Phase 1/2a clinical trial evaluating CLN-081 for the treatment of EGFR exon 20 insertion mutant non-small cell lung cancer (NSCLC) will be presented as a poster presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Cullinan Oncology, SEP 17, 2020, View Source [SID1234565312]).
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Poster Title: Preliminary Safety and Activity of CLN-081 in NSCLC with EGFR Exon 20 Insertion Mutations (Ins20)
Abstract Number: 2133
Poster Number: 1345P
Session Date & Time: From 09:00 Thursday, 17 September 2020 until 20:00 Monday, 21 September 2020.
The poster presentation will summarize the initial Phase 1 experience with CLN-081 up to the data cutoff of September 1, 2020, including data on 22 patients treated at dose levels ranging from 30-150 mg administered orally twice daily. CLN-081 demonstrated acceptable safety, with no dose-limiting toxicities (DLT) and no Grade 3 or greater drug-related adverse events. The most common drug-related adverse events included rash and dry skin, with only one case of Grade 1 drug-related diarrhea being observed.
In this group of heavily pretreated patients with EGFR exon-20 mutant NSCLC (over 80% with 2 or more prior lines of systemic therapy), encouraging preliminary antitumor activity was observed across multiple dose levels, including the initial dose level of 30 mg twice daily. Of the initial 22 patients, 17 were evaluable for objective response at the time of data cutoff, and 5 had not yet reached their initial scan. Of the 17 response evaluable patients, 6 experienced an objective response, including 2 patients with a confirmed partial response, 3 patients with ongoing partial responses not yet reaching a confirmatory scan, and 1 with an unconfirmed partial response. Among the 11 remaining response evaluable patients with a best response of stable disease, the change in target lesions ranged from +3% to -21%. Of these 11 patients, 9 patients remained on treatment with stable disease at the data cutoff.
Commenting on the preliminary data, Jon Wigginton, Cullinan Oncology’s Chief Medical Officer (CMO) stated, "We are encouraged with CLN-081’s initial safety and efficacy data in this very difficult to treat patient population, with antitumor activity across a broad range of doses tested to date and an acceptable safety profile. Guided by this data, we look forward to defining the recommended phase 2 dose of CLN-081, and initiating discussions with regulators regarding the future clinical development path for the program."
The accepted abstract is now available on the ESMO (Free ESMO Whitepaper) conference website HERE. The poster can be viewed on the Cullinan Oncology website HERE.