June 18, 2019

Impact Level: High

  • FDA has granted accelerated approval to Keytruda (pembrolizumab) monotherapy for 3L treatment of metastatic SCLC. According to Keytruda’s revised label, it is indicated for use after platinum-based chemotherapy and one other line of therapy.
  • This approval is based on pooled data from the KEYNOTE-158 (Phase 2) and KEYNOTE-028 (Phase 1b) trials.

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May 20, 2019

Impact Level: Moderate

  • Merck has announced that its Phase 3 KEYNOTE-119 trial assessing Keytruda (pembrolizumab) monotherapy compared to chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in 2L and 3L metastatic triple-negative breast cancer (TNBC) patients did not meet the primary endpoint of OS.
  • In accordance with the study protocol, other endpoints (PFS, ORR, disease control rate, and duration of response) were not formally tested since OS was not met.
  • Merck plans to present these results at an upcoming medical conference.

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May 14, 2019

Impact Level: Moderate

  • The LIBERTY 1 study met its primary efficacy endpoint with 73.4% of women receiving once daily oral relugolix combination therapy achieving the responder criteria compared with 18.9% of women receiving placebo (p < 0.0001). Response was defined as a menstrual blood loss volume of less than 80 mL and a 50 percent or greater reduction from baseline in menstrual blood loss volume during the last 35 days of the 24-week treatment period.

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May 7, 2019

Impact level: Moderate

  • Sutro has provided updates on preclinical BCMA ADC and BCMA/CD3 bispecific antibody programs that are part of a Celgene immuno-oncology collaboration formed in 2014.

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April 25, 2019

Impact level: High

  • According to an updated label, FDA has granted accelerated approval to use of Keytruda (pembrolizumab; PD-1) in combination with Inlyta (axitinib; TKI) in 1L renal cell carcinoma (RCC).

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April 22, 2019

Impact Level: High

  • Novartis has contributed $75 million towards a Series C financing for CAR-T company Poseida, which totaled $142 million from current and new investors.

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