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Lupus Clinical Trials

New Medical Therapies™

Anemia; Non-Small-Cell Lung Cancer

Patient Medical Areas

June 23, 2014

Novartis reported phase I trial results of Zykadia (LDK378) in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). The 246 patients with ALK+ NSCLC in this single-arm study received ceritinib 750mg ALK+ daily. Findings from the study showed patients treated with ceritinib achieved an ORR of 58.5% [95% CI, 52.1-64.8%] and a median PFS of 8.2 months [95% CI, 6.7-10.1 months]. The median duration of response was 9.7 months [95% CI, 7.0-11.4 months], with a median time to first response of six weeks after starting treatment. Among 163 patients receiving 750 mg of ceritinib daily and who were previously treated with the commonly prescribed ALK inhibitor crizotinib, ORR was 54.6% [95% CI, 46.6-62.4%] and PFS was 6.9 months [95% CI, 5.4-8.4 months]. In 83 patients who had not received prior treatment with an ALK inhibitor, ORR was 66.3% [95% CI, 55.1-76.3%] and PFS had not been reached. In the 124 patients who started the study with brain metastases, ceritinib achieved an ORR of 54.0% [95% CI, 44.9-63.0%] and a median PFS of 6.9 months [95% CI, 5.4-8.4 months]. Tumor shrinkage was seen in 50.0% of patients [49 of 98 patients; 95% CI, 39.7-60.3%] with brain metastases who had received previous ALK inhibitor therapy, while 69.2% of patients [18 of 26 patients; 95% CI, 48.2-85.7%] with brain metastases who were not previously treated achieved tumor shrinkage following treatment with ceritinib.

April 7, 2014

Novartis released results of a phase I study of LDK378 in 130 patients for the treatment of advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC). Of 114 ALK+ NSCLC patients treated with LDK378 at 400mg or higher per day, 80 had progressed during or following treatment with crizotinib, and 34 patients with ALK+ NSCLC were crizotinib-naive. The maximum tolerated dose observed in the study was 750mg per day. The median duration of response for the 66 responding patients treated at 400mg or higher per day was 8.2 months [95% CI; 6.9-11.4 months]. In all, 114 ALK+ NSCLC patients treated at 400mg or higher per day, median progression-free survival was 7 months [95% CI; 5.6-9.5 months]. In the 114 ALK+ NSCLC patients treated with LDK378 at 400mg or higher per day, the overall response rate (ORR) was 58% [95% CI; 48-67%] (1 complete response [CR] and 65 partial responses [PR]), which includes those patients who had progressed during or after crizotinib therapy (ORR 56% [95% CI; 45-67%]) and those who were crizotinibnaive (ORR 62% [95% CI; 44-78%]). In the 78 patients with ALK+ NSCLC who received LDK378 at the maximum tolerated dose of 750mg per day, the ORR was 59% [95% CI; 47-70%] (46 PRs), which includes those who had progressed during or after crizotinib therapy (ORR 56% [95% CI; 41-70%]) and those who were crizotinib-naive (ORR 64% [95% CI; 44-81%]). The most frequent adverse events were nausea (82%), diarrhea (75%), vomiting (65%), fatigue (47%) and increased alanine aminotransferase levels (35%). At the 750mg dose level, 50 of 81 patients (62%) required at least one dose reduction, of which 32 occurred in cycle three or later. The FDA has accepted regulatory filings for LDK378.

July 9, 2012

Synta Pharmaceuticals reported interim results from a phase IIb/III trial of ganetespib in combination with docetaxel for the treatment of advanced non-small cell lung cancer (NSCLC). This multi-arm, randomized, open-label phase IIb part of the GALAXY study enrolled 183 patients to date with stage IIIB/IV NSCLC who have progressed following one prior line of therapy. All subjects received a standard regimen of docetaxel 75mg/m2 on Day 1 of a 21-day cycle; subjects in the combination arm receive in addition ganetespib 150mg/m2 on Day 1 and 15. Both primary endpoints were met based on RECIST 1.1 criteria. Subjects with elevated baseline level of serum LDH (lactate dehydrogenase) who received a combination of ganetespib and docetaxel had a median PFS of 4.2 months, compared to 1.4 months in those treated with only docetaxel; subjects with a tumor KRAS mutation receiving the combination treatment had a median PFS of 4.2 months, while the docetaxel group had a PFS of 1.6 months. The treatment was well tolerated. The most frequent adverse events were neutropenia, diarrhea and fatigue. Synta Pharmaceuticals will continue to enroll more subjects in the phase IIb trial. The transition into phase III is expected later this year.

June 11, 2012

Boehringer Ingelheim issued results from a phase III trial of afatinib as a first-line treatment for stage IIIb or IV non-small cell lung cancer (NSCLC). This randomized, open-label, comparative study, LUX-Lung 3, enrolled 345 patients with NSCLC harboring an epidermal growth factor receptor (EGFR) mutation. Subjects received afatinib (n≡230) or pemetrexed/cisplatin (n≡115). The study met its primary endpoint of progression-free survival (PFS). In the general population, afatinib-dosed subjects averaged an 11.1 month PFS versus 6.9 months PFS for subjects dosed with pemetrexed/cisplatin. The hazard ratio was 0.58 (95% CI: 0.43-0.78) (p≡0.0004). In the sub-population of patients with the most common EGFR mutations (Del19 and L858R), afatinib-dosed subjects had a PFS of 13.6 months versus 6.9 months in the chemotherapy arm. The hazard ratio in this patient subset was 0.47 (95% CI: 0.34-0.65) (p<0.0001). The most common adverse events were diarrhea, rash and paronychia.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.