Product Development

AstraZeneca’s (LON:AZN) Phase III study of Tagrisso (osimertinib) requires at least a 22-month progression-free survival (PFS) in order to be clinically viable in first-line EGFR mutant non-small-cell lung cancer (NSCLC), experts said.

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United Therapeutics’ (NASDAQ:UTHR) Phase III FREEDOM-EV design and resulting label for Orenitram (oral treprostinil) allowing only one background therapy will significantly hamper uptake in pulmonary arterial hypertension (PAH), experts said. Dosing and titration challenges compared to competitors will also likely deter widespread use, they added.

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AnaptysBio’s (NASDAQ:ANAB) Phase II study with its anti-IL33 antibody ANB020 has encouraging preclinical data offering a sound rationale for Phase II efficacy, experts said. However, long-term safety data in humans will be needed to allay major concerns, they added.

Some analysts have noted the ‘blockbuster potential’ ANB020 could make potentially USD 2.8bn in 2027, but others have also pointed out that it is lagging in development compared to Phase III competitors from Aimmune Therapeutics (NASDAQ:AIMT) and DBV Technologies(NASDAQ:DBVT).

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Johnson & Johnson’s (NYSE:JNJ) Tremfya (guselkumab) for moderate-to-severe psoriasis is likely to be in formulary tier 3 or 4, due to a crowded market and its potentially high price, experts said. However, Tremfya could have preferential choice in tier 3 due to its improved dosing over other tier 3 options and future real-world data, some added. It could also move to tier 2 due to clinical similarities with Johnson & Johnson’s (J&J’s) Stelara (ustekinumab) but will face major roadblocks from established competition, others said.

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Merck’s (NYSE:MRK) enrollment pause triggered by deaths in its Phase III studies for Keytruda (pembrolizumab) in multiple myeloma (MM), has left experts perplexed as to the cause of the deaths, though autoimmune toxicity remains a possibility.

Still, some experts said it is unlikely to damage the development of other PD-1 and PD-L1 checkpoint inhibitors in MM, citing the fact that both another study of Keytruda in MM, as well as studies of other checkpoint inhibitors using combinations -- similar to the ones in the paused trials -- all remain ongoing.

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Zynerba Pharmaceuticals' (NASDAQ:ZYNE) ZYN002 cannabinoid (CBD) in fragile X syndrome (FXS) has prompted expert uncertainty over whether preclinical efficacy will translate to clinical efficacy in the ongoing Phase I/II trial despite mechanistic rationale. Whereas mouse model success suggests a MOA worth investigating, experts noted rival FXS treatments have failed to translate murine efficacy into the clinic.

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The Medicines Company’s (NASDAQ:MDCO) Vabomere (meropenem-vaborabactam) will chiefly be used as a second-line option for complicated urinary tract infection (cUTI) following expected FDA approval, said experts. They were divided over Vabomere’s ranking among other second-line competitors and antibiotics in late-stage development, especially its biggest potential opposition, Achaogen’s (NASDAQ:AKAO) plazomicin.

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Eli Lilly (NYSE:LLY) has increased the doses of solanezumab in both the A4 and DIAN studies of Alzheimer’s disease (AD), according to two sources familiar with the studies. The A4 study duration has also been extended by one and a half years, they added.

The sources did not comment on the new dose being used in the A4 study. The doses on both ClinicalTrials.gov pages are still listed as 400mg and have not been updated since the alleged protocol amendments. 

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Kite Pharma’s (NASDAQ:KITE) Phase I/II ZUMA-4 study of axicabtagene ciloleucel (axi-cel) in pediatric acute lymphoblastic leukemia (ALL) has a protocol amendment that allows patients who have previously received Amgen’s (NASDAQ:AMGN) Blincyto (blinatumomab) to enter the study, a source said.

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Novartis (VTX:NOVN) temporarily encountered manufacturing problems at its European chimeric antigen receptor T-cell (CAR-T) manufacturing facility, forcing at least one site in the Phase II JULIET trial of tisagenlecleucel-T in diffuse large B-cell lymphoma (DLBCL) to go through the US facility, a source with knowledge of the situation said. The logistical issue occurred after the European sites’ activation and resulted in lengthening the time between apheresis and reinfusion, the source added. 

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