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15:29 EST Merck, Eisai present data from Phase 3 CLEAR study - Merck, known as MSD outside the United States and Canada, and Eisai have announced the first presentation of new investigational data from the pivotal Phase 3 CLEAR study in an oral presentation session at the virtual 2021 Genitourinary Cancers Symposium and simultaneously published in the New England Journal of Medicine. The trial evaluated the combinations of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma. KEYTRUDA plus LENVIMA demonstrated statistically significant and clinically meaningful improvements in progression-free survival, overall survival and objective response rate versus sunitinib. LENVIMA plus everolimus also showed statistically significant improvements in PFS and ORR versus sunitinib. In an exploratory analysis, results for PFS and OS were consistent across prespecified Memorial Sloan Kettering Cancer Center risk groups. In the trial's primary endpoint of PFS, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 61%, with a median PFS of 23.9 months versus 9.2 months for patients who received sunitinib. In the trial's key secondary endpoints, KEYTRUDA plus LENVIMA reduced the risk of death by 34% versus patients who received sunitinib. Median OS was not reached in either treatment arm after a median follow-up of 27 months. Treatment with KEYTRUDA plus LENVIMA resulted in an ORR of 71.0%, with a complete response rate of 16.1% and a partial response rate of 54.9%, versus an ORR of 36.1%, with a CR rate of 4.2% and a PR rate of 31.9%, for patients who received sunitinib. Median duration of response for patients who received KEYTRUDA plus LENVIMA was 25.8 months versus 14.6 months for patients who received sunitinib. In the trial's second experimental treatment arm, LENVIMA plus everolimus reduced the risk of disease progression or death by 35%, with a median PFS of 14.7 months versus 9.2 months for patients who received sunitinib. LENVIMA plus everolimus did not demonstrate an improvement in OS compared with sunitinib. Median OS was not reached in either treatment arm after a median follow-up of 27 months. The ORR was 53.5%, with a CR rate of 9.8% and a PR rate of 43.7%, for patients who received LENVIMA plus everolimus versus 36.1%, with a CR rate of 4.2% and a PR rate of 31.9%, for patients who received sunitinib. Median DOR for patients who received LENVIMA plus everolimus was 16.6 months versus 14.6 months for patients who received sunitinib. In the KEYTRUDA plus LENVIMA arm, treatment-related adverse events led to discontinuation of KEYTRUDA in 25.0% of patients, of LENVIMA in 18.5% of patients, and of both in 9.7% of patients. In the LENVIMA plus everolimus arm, TRAEs led to discontinuation of LENVIMA in 16.1% of patients, of everolimus in 19.2% of patients, and of both in 13.5% of patients. In the sunitinib arm, TRAEs led to discontinuation of sunitinib 10.0% of patients. Grade 5 TRAEs occurred in 1.1% of patients in the KEYTRUDA plus LENVIMA arm, in 0.8% of patients in the LENVIMA plus everolimus arm, and in 0.3% of patients in the sunitinib arm. Grade greater than or equal to 3 TRAEs occurred in 71.6% of patients in the KEYTRUDA plus LENVIMA arm, in 73.0% of patients in the LENVIMA plus everolimus arm, and in 58.8% of patients in the sunitinib arm.

15:18 EST Kodiak Sciences announces data from ongoing Phase 1b study of KSI-301 - Kodiak Sciences has announced promising 1-year durability, efficacy and safety data from the ongoing Phase 1b study of its investigational therapy KSI-301, an intravitreal anti-VEGF antibody biopolymer conjugate, in patients with treatment-naive wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. "The Year 1 data for KSI-301 presented today at Angiogenesis and the data presented on other late-stage molecules at the meeting continue to support a highly-differentiated durability profile for KSI-301 along with strong efficacy and an encouraging safety profile. We observed that two-thirds of patients in each disease cohort achieve a 6-month or longer treatment-free interval at the one-year mark - 66% of wet AMD patients, 69% of DME patients and 66% of RVO patients," said Jason Ehrlich, Chief Medical Officer at Kodiak Sciences. "Moreover, 78% of wet AMD patients and 84% of DME patients were on a 4-month or longer interval at Year 1, as were 75% of RVO patients. Said differently, an average of only 2.0, 1.0, and 1.7 retreatments were given in the ten months following the three loading doses in AMD, DME, and RVO patients respectively. Remarkably, 54% of wet AMD patients required only one retreatment and 50% of DME patients required no retreatment in Year 1." "We are seeing strong anti-VEGF efficacy for KSI-301, when we look to historical data for anti-VEGFs and new late-stage trial data presented at today's meeting," continued Ehrlich. "In wet AMD, we observed a mean 5.7 letter improvement, to 69.7 ETDRS eye chart letters at Year 1. In DME, we observed a mean 7.6 letter improvement to 73.9 eye chart letters at Year 1, and in RVO we observed a mean 22.2 letter improvement to 76.6 letters. We also remain pleased with the safety profile of KSI-301, now with over 700 doses given in the Phase 1b study and over 2,000 administered across the ongoing KSI-301 clinical development program." "KSI-301 has the potential to become the standard of care for patients with VEGF-mediated retinal diseases," said Victor Perlroth, Chief Executive Officer of Kodiak Sciences. "Our Year 1 Phase 1b data, with two in three patients achieving a 6-month or longer treatment-free interval at Year 1, show the potential for KSI-301 to provide tangible benefits for patients and retina specialists alike. The DAZZLE wet AMD study is fully recruited with an expected data read-out in early 2022, and our GLEAM and GLIMMER studies in DME and BEACON study in RVO are actively recruiting. We are grateful for the enthusiastic support of these studies from the ophthalmology community."