Arriving Late To The FDA’s Multiple Myeloma Pembrolizumab Pomalidomide Lenalidomide Halt Decision — But Merck Likely To Open Off Tomorrow…

We were (quite happily) out, and off grid all night — with our fun-loving adult kids, and so arrive here after midnight on Tuesday/early Wednesday — to express our concern. There was a foreshadowing of all this, at mid-June 2017 with the studies’ safety monitors imposing a pause, in enrollments. But now FDA has stopped these studies in total. I would expect a one to two per cent additional decline in Merck’s NYSE price, beyond the decline in the after-hours session on the NASDAQ, tonight. Sad news, but patients (and patient safety — i.e., “first, do no harm“) must come first.

Much has already been written, in the financial press — so I’ll simply quote the full release here. Some of the most difficult news appears near the end of the presser, with some specificity around non-disease-progression related deaths (even in other cancers):

. . . .The FDA has determined that the data available at the present time indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma. All patients enrolled in KEYNOTE-183 and KEYNOTE-185 and those in the KEYTRUDA /lenalidomide /dexamethasone cohort in KEYNOTE-023 will discontinue investigational treatment with KEYTRUDA. This clinical hold does not apply to other studies with KEYTRUDA. . . .

KEYTRUDA (pembrolizumab) was discontinued due to adverse reactions in 5% of 210 patients with cHL, and treatment was interrupted due to adverse reactions in 26% of patients. Fifteen percent (15%) of patients had an adverse reaction requiring systemic corticosteroid therapy. Serious adverse reactions occurred in 16% of patients. The most frequent serious adverse reactions (≥1%) included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; one from GVHD after subsequent allogeneic HSCT and one from septic shock. The most common adverse reactions (occurring in ≥20% of patients) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%). . . .

KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reactions (in ≥20% of patients) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%). Eighteen patients (5%) died from causes other than disease progression. Five patients (1.4%) who were treated with KEYTRUDA experienced sepsis which led to death, and 3 patients (0.8%) experienced pneumonia which led to death. Adverse reactions leading to interruption of KEYTRUDA occurred in 22% of patients; the most common (≥1%) were liver enzyme increase, diarrhea, urinary tract infection, acute kidney injury, fatigue, joint pain, and pneumonia. Serious adverse reactions occurred in 42% of patients, the most frequent (≥2%) of which were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis.

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Adverse reactions leading to interruption of KEYTRUDA occurred in 20% of patients; the most common (≥1%) were urinary tract infection (1.5%), diarrhea (1.5%), and colitis (1.1%). The most common adverse reactions (≥20%) in patients who received KEYTRUDA vs those who received chemotherapy were fatigue (38% vs 56%), musculoskeletal pain (32% vs 27%), pruritus (23% vs 6%), decreased appetite (21% vs 21%), nausea (21% vs 29%), and rash (20% vs 13%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients, the most frequent (≥2%) of which were urinary tract infection, pneumonia, anemia, and pneumonitis. . . .

Now you know. I would expect some share price declines at BMS and at Roche/Genentech as well, in the morning — as (at least at this early stage) there would be little reason not to think this might be a class wide effect, with the Celgene agent(s). But we shall see. G’night to all of good will — and in unrelated news, Cassini is completing Ring Plunge 12 as I type this. . . we should see a twisty, copper colored “signal acquired” confirmation — by tomorrow night. . . .

नमस्ते

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