Kelsey Goodwin

Kelsey Goodwin asked about the company's preparations for the upcoming ODAC meeting, where they anticipate the most pushback, and what they consider their strongest counterarguments.

Answer

CEO Liz Barrett detailed extensive preparations, including multiple mock ODAC panels. She believes the main challenge will be contextualizing the data from the single-arm ENVISION study. Chief Medical Officer Dr. Mark Schoenberg highlighted their strongest arguments: the remarkable efficacy in a recurrent population (80% CR, >80% durability at 18 months), a favorable safety profile, and the support of two highly credible Key Opinion Leaders (KOLs) who will be presenting.

Kelsey Goodwin asked about the expected timing for FDA notification of an ODAC meeting and the potential impact of the initial miscellaneous J-code on UGN-102's launch uptake.

Answer

President and CEO Liz Barrett anticipates an ODAC in the April-May 2025 timeframe and expects to receive notification by February or March. CCO David Lin and CEO Liz Barrett explained that while the miscellaneous J-code might cause some initial hesitation in community settings, they will provide robust reimbursement support, and expect initial uptake to be strong in hospitals, similar to the JELMYTO launch experience.

An analyst on behalf of Kelsey Goodwin from Guggenheim Partners asked about the efficacy benchmark for the LORIKEET trial and what would be considered a successful outcome for the update expected in the first half of 2025.

Answer

Dr. Scott Koenig, President and CEO, noted that historical studies of docetaxel alone show an rPFS of approximately 8 to 8.6 months. He stated that while MacroGenics has not declared a specific target, a successful outcome for the combination would certainly involve a significant, double-digit month improvement in rPFS.

Kelsey Goodwin from Guggenheim Securities asked for an update on durability expectations for vobra duo and whether the swimmer plots for RECIST-evaluable patients were representative of the broader study population.

Answer

Dr. Scott Koenig, President and CEO, noted it was too early to predict final durability as a majority of patients (62.5% in the 2.7 mg/kg arm) remain on treatment. He affirmed that the presented swimmer plots are representative of the overall patient population, including those with non-RECIST evaluable disease like bony metastases.

Asked about the key areas of differentiation for Abecma emerging from real-world data and for more details on the expansion of the treatment site footprint.

Answer

The company responded that expanding the site footprint is an important commercial driver for patient access. Regarding real-world evidence, they see data showing reproducible or even better efficacy than the pivotal study and a favorable safety profile, particularly concerning delayed neurotoxicities, infections, and non-relapsed mortality.