The health care sector is descending on Chicago as the American Society of Clinical Oncology (ASCO) annual meeting nears. This meeting draws many companies and analysts alike, looking for the new and best treatments for cancer, as well as updates on current clinical trials. Merrill Lynch is one of the major firms that will be in attendance, and it has issued a report on what it is looking for at this meeting.
Merrill Lynch believes that, unlike in prior years, there is no single dataset for any of its large cap names that will be thesis changing. However, there are several datasets that will give the firm incremental insights into various pipeline opportunities, which it highlighted in its report.
On July 3, Eli Lilly and Co. (NYSE: LLY) will present 12-month data from its Monarch-1 study (abemaciclib in refractory HR+/HER2- metastatic breast cancer patients). So far, eight-month data was released in the abstract, showing an overall response rate (ORR) of 17.4%, a clinical benefit rate of 42.4% and progression free survival (PFS) of 5.7 months, which disappointed the street due to elevated expectations based on Phase 1 data (ORR of roughly 30%) and the notion that Eli Lilly may be unable to file for approval on this single dataset.
The brokerage firm detailed in its report:
However, we would highlight the important takeaway here is that abema has demonstrated a superior profile vs. Pfizer Inc. (NYSE: PFE)’s Ibrance (which showed an ORR of 7% in this setting and PFS of 3.8 months), which could lead to further differentiation in the first line setting. Importantly, discontinuations due to adverse events (AE) were 6.8%, implying a commercially viable profile. At ASCO, key details we are looking for are 1) duration of response, 2) details on GI side effects, specifically diarrhea, including rate, duration, number of episodes (first dose phenomenon?) and treatment given (diarrhea was one of the most common AE’s in the prior Ph. I single-agent trial – 68%). We will also follow the small number of patients (n=3) showing abema penetrates brain metastases in metastatic breast cancer.
The (Stemcentrx) Rova-T data from AbbVie Inc. (NYSE: ABBV) in small cell lung cancer (SCLC) will be presented as a late-breaker. The key focus of the presentation will be overall survival (OS). In Phase 1/2 studies in relapsed SCLC, Rova-T demonstrated an ORR of 44% to 45%. Keep in mind that despite the challenges of cross trial comparison, Merrill Lynch notes a superior ORR rate to the Opdivo/Yervoy combo and Keytruda presented at ASCO 2015.
ProNAi Therapeutics Inc. (NASDAQ: DNAI) will release data from its Phase 2 Wolverine study in diffuse large B cell lymphoma (DLBCL) on June 6 at an investor event, as well as in a poster. While we have seen efficacy (75% complete responses in heavily pre-treated DLBCL) in a limited number of patients in this population, this study is critical to validate the company’s DNA interference platform. Merrill Lynch is also looking for updated safety and tolerability, which appeared favorable in earlier trials, with no evidence of tumor lysis syndrome.
Bristol-Myers Squibb Co. (NYSE: BMY) will present updated CM-012 data that will give additional combo insights. The firm is focusing on the OS and AE metrics from this. Previously released CM-012 Opdivo/Yervoy data from this trial showed an ORR of 31%. Tumor growth dynamic results will be presented, which could give additional insight into the Phase 3 dosing regimen selection.
Merck & Co. (NYSE: MRK) will present data showing Keytruda’s efficacy in combo with various chemo regimens in first line NSCLC. ORRs in the abstract were 48% to 71%, which appears competitive with Roche’s chemo-combo results.
Shares of Eli Lilly were trading at $75.18 Thursday morning. The stock has a consensus analyst price target of $95.71, which compares to Merrill Lynch’s price objective of $108. The stock has a 52-week trading range of $67.88 to $92.85.
Pfizer shares were trading at $34.71, with a consensus price target of $38.67 and a 52-week range of $28.25 to $36.46. Merrill Lynch has a price objective of $39.
AbbVie was trading at $63.78 a share, with a consensus price target of $71.06 and a price objective of $67 from Merrill Lynch. The stock has a 52-week range of $45.45 to $71.60.
Shares of ProNAi were trading at $6.31, in a 52-week range of $4.48 to $33.75. The consensus price target is $29.50. Merrill Lynch has a $35 price objective.
Bristol-Myers shares were last seen at $72.31, with a price objective of $74 from Merrill Lynch. The consensus price target is $76.29, while the 52-week range is $51.82 to $73.06.
Shares of Merck were at $56.71. The consensus price target is $61.55, and the 52-week trading range is $45.69 to $60.21. Merrill Lynch has a $56 price objective.
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