Merck KGaA scraps a controversial PhIII comeback attempt for cancer vaccine

About a year ago Merck KGaA made the controversial decision to revive its late-stage program for the cancer vaccine Stimuvax, trying to start off fresh by renaming it tecemotide and pointing it toward a subpopulation of non-small cell lung cancer patients which appeared to respond in its very big failed Phase III. Today, the program is--once again--officially terminated. The German biopharma company made the embarrassing decision to back out and dump its two monotherapy studies after yet another recent trial failure in Japan finally convinced them there was nothing there.

Merck KGaA's decision to try and salvage tecemotide, which was in-licensed from Oncothyreon ($ONTY), was met with considerable skepticism at the time. Subgroup analysis, in this case tracking a response in a group of patients which had also received concurrent chemotherapy and radiation, can be a notoriously misleading approach to drug development. For Merck KGaA, which heralded this study as a leading effort in its comeback R&D attempt after years of ineffective development work, it was a damaging turn.

Merck KGaA doubled down on the cancer vaccine after a series of major setbacks had raised serious questions about the entire field. GlaxoSmithKline's ($GSK) closely watched MAGE A-3 had just failed a key endpoint and was headed for the scrap heap. Dendreon's ($DNDN) Provenge has never been able to live up to the high hopes that greeted its approval. There have been other R&D setbacks as well, forcing the remaining players to look at more realistic combo approaches to establishing a positive therapeutic role for the vaccine group. And then a few weeks ago Merck KGaA was forced to concede that its program had flunked the primary and all the secondary endpoints in the study in Japan.

For tecemotide, a MUC1 antigen-specific cancer vaccine designed to rouse the body's immune system to attack expressing the cell-surface glycoprotein, that was the last straw.

Luciano Rossetti

"While the data from the exploratory subgroup analysis in the START trial1 generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals," said R&D chief Luciano Rossetti in a statement. "Therefore, we have decided to discontinue the development of tecemotide as a monotherapy in NSCLC in order to refocus our efforts on other promising candidates in our pipeline, like our anti-PD-L1 antibody MSB0010718C. We remain committed to developing new treatment options for patients with difficult-to-treat cancers."

The German drugmaker twice struck out in trying to develop a successor to Rebif, its MS-treating injection that is quickly losing ground to Tecfidera. Merck KGaA was once considered a leader in the race to commercialize the first oral treatment for the muscle-destroying disease with its candidate cladribine, but serious safety issues led to regulatory rejections in the U.S. and Europe, and the company nixed the program in 2011. After that, the company restructured its R&D effort, laying off a big group of staffers in Switzerland and trying to set the stage for a new strategy. But only 6 months after Annalisa Jenkins was named head of global R&D at Merck KGaA, she left with no reason provided for the abrupt exit. And despite repeated assurances that drug deals are in the offing, the disarray at Merck KGaA shows signs of growing worse.

- here's the release (PDF)

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