This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Lung Drug Data Showdown: InterMune vs. Boehringer Ingelheim

All-cause mortality in the pooled INPULSIS studies was 5.5% in the nintedanib arms versus 7.8% in the placebo arms -- a 30% relative reduction in the risk of death favoring nintedanib but not statistically significant.

The death rate due to respiratory cause was 3.8% in the nintedanib patients compared to 5% in the placebo groups -- a 26% relative reduction in risk of death but again, not statistically significant.

Switching to InterMune's ASCEND study, the rate of all-cause mortality in pirfenidone-treated patients was 4% versus 7.2% in placebo patients -- a 45% relative reduction in the risk of death but not statistically significant.

With FDA's blessing, InterMune pooled survival data from ASCEND with the previous phase III CAPACITY studies. When these studies are combined, the death rate in the pirfenidone arm is 3.5% compared to 6.7% in placebo-treated patients -- a 48% relative reduction in the risk, which is statistically significant.

Must Read: AstraZeneca Drug Shrinks Lung Cancers Typically Hardened by Genetic Mutation

InterMune can make a legitimate claim to a mortality benefit for pirfenidone in IPF with the pooled data from the ASCEND and CAPACITY trials. How this survival benefit shows up in the pirfenidone label is yet to be determined.

Boehringer says the INPULSIS studies were not powered to demonstrate a nintedanib survival benefit. It's interesting however, that the two INPULSIS studies enrolled 1,061 IPF patients, while the combined ASCEND and CAPACITY studies enrolled 1,247 patients. The difference in size isn't all that large.

Moving to safety and tolerability:

Ten IPF patients treated with nintedanib suffered heart attacks in the two INPULSIS studies (five in each study) compared to two heart attacks reported in placebo-treated patients (one in each study.) Two of the nintedanib heart attacks were fatal; one of the placebo patients also died.

The rate of serious adverse events listed as "cardiac disorder" was 5% in the nintedanib arms (pooled) versus 5.4% in the placebo arms (also pooled.)

The rate of "serious ischemic disease" reported in the INPULSIS studies was 2.4% in both the nintedanib and placebo arms.

There's some new and interesting liver safety data being reported today for the first time from Boehringer's nintedanib studies. Six patients (0.9%) discontinued nintedanib treatment because of elevations in AST, ALT or bilirubin levels -- all markers for liver toxicity. There were no cases of Hy's Law reported in the studies.

Eight percent of nintedanib patients experienced elevation of ALT or AST three times the upper limit of normal or greater.

The comparable rate of ALT/AST elevations above three times the upper limit of normal for InterMune's pirfenidone was 3%. One case of Hy's Law in a pirfenidone-treated patient was reported.

Investors have previously raised some concerns about the liver safety of pirfenidone, but these new nintedanib data suggest Boehringer's drug is no better, perhaps worse.

As previously reported, the rate of diarrhea in the nintedanib patients was 61.5% and 63.2% in the two INPULSIS studies. The placebo-adjusted rate of diarrhea was 43% and 45%. However, only 5% of patients discontinued from the two studies due to the diarrhea.

Other gastrointestinal-related adverse events of note were 17% and 19% placebo-adjusted rates of nausea. Vomiting was reported in 11% and 7% of patients, adjusted for placebo.

Moving to InterMune's study, rash was reported by 28% of pirfenidone-treated patients compared to 8.7% in the placebo arm -- a 19% difference. The placebo-adjusted rate of nausea attributed to pirfenidone was 23%, vomiting 4%.

There's a lot to digest here already so I won't go into detail on the key secondary efficacy endpoints of the respective IPF studies except to recount that InterMune's pirfenidone demonstrated a progression-free survival benefit while Boehringer showed a reduction in the time to first acute exacerbation in INPULSIS-2 but not INPULSIS-1.

But let's end with some more comparative efficacy data and slides.

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ITMN $73.89 -0.03%
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs