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Anemia; Non-Small-Cell Lung Cancer
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.