Today, Novartis hosted its Meet the Management investor event and provided updates to its commercial and pipeline developments. Below, FENIX provides cardiometabolic-related highlights and insights from the event relating to Entresto, inclisiran (PCSK9i), and pelacarsen (LP(a)).
On Tuesday, July 21, Novartis held their Q2 2020 earnings call (press release / financial report / presentation). Of note, Kymriah sales were resilient despite COVID-19, growing +103% WW QoQ and +27% WW versus Q1 2020. Interestingly, the Ph3 OBERON trial investigating Kymriah in adult ALL has been omitted from Novartis’s pipeline. Below, Celltelligence provides thoughts on Novartis’s cell therapy program, particularly surrounding the withdrawal of the Ph3 OBERON study and the ongoing risks posed by competitors, Gilead and Autolus, on Kymriah’s continued sales growth.
On Friday, July 17, BMS announced (press release) that the EMA has validated BMS’s MAA for lisocabtagene maraleucel (liso-cel). Below, Celltelligence provides thoughts on Liso-cel’s MAA and the potential impact of a Liso-cel approval for Novartis and Gilead (Kite).
On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).
On Monday, June 15, Novartis held an investor call (presentation), highlighting advances to their activated rapid manufacturing (ARM) platform for cell therapy, and their assessment of the community setting for CD19 CAR-T therapies. Below, FENIX provides thoughts on the significance of the ARM platform compared to other rapid manufacturing methods, and the potential impact Kymriah could have outside Centers of Excellence (COE).
Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which reported a slight dip in Q1 2020 sales (see previous FENIX insight). Below, FENIX provides thoughts on published revenues and possible factors influencing HCPs’ CAR-T prescribing preferences.
On Tuesday, April 28, Novartis held their Q1 2020 earnings call (press release / financial report / slides). Of note, Kymriah sales fell slightly versus the previous quarter (Q4 2019), possibly due to the impact of COVID-19. However, Novartis underlined its confidence in the oncology field’s “resilience” and the company’s full-year sales outlook. Below, FENIX provides thoughts on Novartis’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.
A new Novartis-sponsored Ph1 trial has been detected for the BCMA CAR-T, PHE885, in ≥3L relapsed and refractory multiple myeloma (RRMM). Of note, the trial uses a new CAR-T manufacturing method. Below, FENIX provides insights on this new trial and how a potentially improved manufacturing process could enhance Novartis’s position compared to the BCMA CAR-T leaders, BMS and Janssen.