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IMGN

ImmunoGen

$2.72

-0.06 (-2.16%)

16:44
09/29/19
09/29
16:44
09/29/19
16:44

ImmunoGen says Phase 3 Forward I trial did not meet primary endpoint

ImmunoGen announced full data and additional exploratory analyses from the Phase 3 Forward I study evaluating mirvetuximab soravtansine compared to chemotherapy in women with folate receptor alpha-positive, platinum-resistant ovarian cancer during an oral presentation at the European Society for Medical Oncology 2019 Congress in Barcelona, Spain. "While it is disappointing that Forward I did not meet the primary endpoint of progression-free survival, mirvetuximab demonstrated consistent and meaningful efficacy signals in patients with high levels of FRalpha expression and was well tolerated with a differentiated safety profile in both the ITT and FRalpha high populations," said Kathleen Moore, Associate Director of Clinical Research at the Stephenson Cancer Center at the University of Oklahoma. The Forward I Phase 3 trial randomized 366 patients 2:1 to receive either mirvetuximab or the physician's choice of single-agent chemotherapy. Eligibility criteria included patients with platinum-resistant ovarian cancer that expressed medium or high levels of FRalpha, who had been treated with up to three prior regimens. The primary endpoint of this study was progression-free survival, which was assessed using the Hochberg procedure in the entire study population and in the subset of patients with high FRalpha expression. The Hochberg procedure enables the simultaneous testing of two overlapping populations. Under this statistical analysis plan, if the p-value of the primary endpoint in either population is greater than 0.05, the p-value in the other population needs to be less than or equal to 0.025 to achieve statistical significance. In the entire study population, the confirmed overall response rate was higher for mirvetuximab than for chemotherapy, without a significant difference in the primary endpoint of PFS or overall survival. In the pre-specified FRalpha high subgroup: Median PFS was longer in patients who received mirvetuximab compared with chemotherapy. Given that the p-value in the entire study population exceeded 0.05, the statistical analysis plan for the study required the p-value in the high subset to be less than or equal to 0.025 to achieve statistical significance. Confirmed ORR was higher for mirvetuximab than for chemotherapy. OS was longer in patients who received mirvetuximab compared with chemotherapy. The trend in improved OS in patients who received mirvetuximab compared with chemotherapy persisted with an additional 6 months of follow-up. Mirvetuximab was well-tolerated, with fewer patients experiencing grade 3 or greater treatment emergent adverse events, fewer dose reductions, and fewer discontinuations due to drug-related TEAEs compared with chemotherapy. The safety profile of mirvetuximab was confirmed. Over twice the percentage of patients who received mirvetuximab compared with chemotherapy reported improved quality of life, as measured by at least a 15-point improvement in the abdominal/GI symptom subscale of the EORTC-QLQ OV28.

  • 29

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IMGN ImmunoGen
$2.72

-0.06 (-2.16%)

05/06/19
COWN
05/06/19
UPGRADE
COWN
Outperform
ImmunoGen upgraded to Outperform from Market Perform at Cowen
Cowen analyst Boris Peaker upgraded ImmunoGen to Outperform from Market Perform, saying the company noted on its Q1 earnings conference call that all secondary endpoints continued to trend positively in FRa high patients from the FORWARD I trial. Peaker tells investors in a research note that he sees additional clarity in the second half of the year after the company meets with the FDA, and says he believes shares are undervalued. If approved, Peaker says he believes that ImmunoGen's drug could acheive peak sales of ~1.6B per year.
05/06/19
05/06/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Sinclair Broadcast (SBGI) upgraded to Buy from Neutral at B. Riley FBR with analyst Barton Crockett saying yhe company's deal to acquire 21 regional sports networks from Disney (DIS) at valuation of $10.6B "looks like a home-run". 2. ImmunoGen (IMGN) upgraded to Buy from Neutral at H.C. Wainwright with analyst Debjit Chattopadhyay seeing 40% downside risk to the stock if the FDA does not consider mirvetuximab to be a clinically meaningful addition to the armametum against ovarian cancer versus a 145% upside potential. 3. Dish (DISH) upgraded to Neutral from Underperform at Credit Suisse with analyst Douglas Mitchelson saying he finds that risk/reward and potential catalysts across wireless and Pay TV are now in balance. 4. Post Holdings (POST) upgraded to Buy from Neutral at Goldman Sachs with analyst Jason English stating he views the recent pullback as a buying opportunity as he thinks transient headwinds were the reason results missed investor expectations in Q2. 5. Dentsply Sirona (XRAY) upgraded to Outperform from Market Perform at Barrington with analyst Michael Petusky saying the company's turnaround is "now on a firm, provable footing". This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
05/15/19
GUGG
05/15/19
DOWNGRADE
GUGG
Neutral
ImmunoGen downgraded to Neutral from Buy at Guggenheim
05/15/19
HCWC
05/15/19
NO CHANGE
Target $4
HCWC
Buy
H.C. Wainwright says 'wrong again' about ImmunoGen, lowers price target to $4
H.C. Wainwright analyst Debjit Chattopadhyay said he had "misplaced optimism" about the path forward for ImmunoGen's mirvetuximab and admits to having been "wrong again" about the stock after the company disclosed that the FDA has recommended a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha-positive, platinum-resistant ovarian cancer. The analyst believes the subsequent study, likely to be initiated during Q4, will likely mimic the FORWARD I Phase 3 program, but focus primarily on high FRalpha expressing patients. He "conservatively" assumes about 36 months from trial start to finish and now thinks potential commercialization won't come until the beginning of 2023. Chattopadhyay lowered his price target on ImmunoGen shares to $4 from $7 but keeps a Buy rating on the stock, which is down 31% to $2.19 in early trading.

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