E****e
发帖数: 315 | 1 from SeekingAlpha
The recent news announcing Genentech’s (DNA) receipt of a “Refuse to File
(RTF)” letter from the FDA for the accelerated approval of the Biologic
License Application (BLA) for trastuzumab-DM1 (T-DM1) has caused a sell-off
in Immunogen, the owner of the technology and partner on the drug with Roche
. According to the FDA letter, the refusal to give the early approval was
because “the trials had not yet exhausted all available drugs approved for
metastatic breast cancer, regardless of HER2 status!
The question is: Is the sell-off a fair market reaction to the news? Our
answer is definitely no. Nothing in the news was related to the drug, its
safety, efficacy, or its breakthrough nature. The FDA did not discuss the
drug’s approvability and has not rejected it. The agency’s letter
constituted a refusal only of an attempt to get the drug early on the market
for the hopeless category of patients with tumor recurrence. Genentech made
this decision based on the results of a single-arm Phase 2 study, which
showed T-DM1 shrank tumors in one-third of women with advanced HER2-positive
breast cancer who had received on average seven prior medicines, including
two HER2-targeted medicines. The results convinced Genentech that TDM-1
works in recurrent HER2 breast cancer that resisted its blockbuster drug
Herceptin and, evidently, the other non-specific treatments.
WOW, said a physician who was hearing the news. She developed HER2 breast
cancer herself and tested positive for BRCA, which means she has inherited
the breast cancer gene. As a matter of fact, her 28 years old daughter
tested also positive for the gene. She has not developed metastasis or any
other tumor recurrence, but she is concerned. Commenting on the FDA letter
explanation to its decision, the physician/patent said, “trying to figure
out what the FDA meant by exhausting all available treatment choices
approved for metastatic breast cancer, the question that keeps crossing my
mind is: Haven’t those patients received prior Herceptin (trastuzumab),
capecitabine, anthracycline, taxane and lapatinib. How much more drugs must
they receive? You know what? The drugs, yes, would be exhausted when
Genentech uses them all, but definitely the patients who would receive them
will be exhausted too. We asked the doctor/patient whether there are
existing data on these drugs that were not used in T-DM1 trials, her answer
was:
Of course the data exist and have been published, yet, why do we need them?
Oncologists know that most non-specific treatments have not helped most HER2
breast cancer even in its early stages, let alone their recurrences. I
wonder why should we withdraw the big hope that HER2 metastatic patients
hanged on since they heard about TDM-1 results – hope that has tremendously
increased since these patients learned about the filing for early approval
of the promising drug. Most these patients might not be around on the
delayed day of the approval.
Herceptin is the first approved HER2 targeted drug. It has improved by far
the bad prognosis of HER2 breast cancer. But the drug has failed to work on
around 50% of the cancer recurrence following a successful initial treatment
. These patients are the candidate forT-DM1, which has demonstrated efficacy
on them.
Trastuzumab-DM1 (T-DM1), in global development by Roche under a
collaboration agreement with ImmunoGen. It onsists of DM1 cell-killing agent
attached to the HER2-binding antibody trastuzumab (Herceptin) using
ImmunoGen’s linker and methods of attachment. The drug is being developed
for all stages of HER2+ metastatic breast cancer (MBC). T-DM1 has
demonstrated the capability of walking the extra step towards killing the
recurrent resistant cancer cells that Herceptin and other drugs failed to
kill. The FDA decision has not affected Genentech’s confidence in the drug
and the firm will continue the EMILIA study, which compares T-DM1 to
lapatinib in combination with capecitabine in people with advanced HER2-
positive breast cancer whose disease has worsened after receiving initial
treatment. ImmunoGen expressed disappointment that there will be a delay in
the opportunity for T-DM1 to be approved for desperate patients and will
continue to focus on the development of its robust and expanding pipeline as
well as advancing its technology through new partnerships.
Currently:
Enrollment is on track in the Phase 3 trial (EMILIA) evaluating T-DM1 for
2nd-line use with 580-patient randomized trial that began in February 2009
and compares T-DM1 – used as a single agent – to lapatinib) plus
capecitabine.
A Phase 3 trial (MARIANNE) for 1st-line trial on route.
Waiting for October to hear the interim data of the phase 2 trial evaluating
T-DM1 for first line treatment. The trial has completed patient enrollment.
The data will be reported at the European Society of Medical Oncology (ESMO
) meeting being held Oct. 8-12, 2010 in Milan, Italy. This trial compares T-
DM1, given as a single agent, to Herceptin (trastuzumab) plus Taxotere (
docetaxel).
Genentech has disclosed upcoming trials to evaluate T-DM1 for early stage
HER2+ breast cancer (adjuvant use) are being considered.
Data from earlier-stage phase 1 and phase 2 clinical trials have been
reported and Information on these and other T-DM1 clinical trials can be
found at ClinicalTrials.gov.
The firm’s pipeline comprises: T-DM1 (see above). Lorvotuzumab, for non-
small-cell-lung cancer, Merkel cell and ovarian cancers, SAR3419, for non-
hogkin’s lymphoma, IMGN 388, for solid tumors. BIIB015, for solid tumors.
BT-062, for multiple myeloma, SAR650984, for lquid tumors, in addition to
other investigational drugs in earlier stages.
Final Note:
We ask those who caused the sell-off in IMGN: Are all these activities and
results worth nothing compared to the refusal to accept earlier approval of
the drug? The FDA has a job to do. We too have a job to do. Let the agency
do its job and let the firms discuss the decision with the agency; it is
their job too. Our job, though, is to assess the value of the firm’s drug
and pipeline.
We believe the T-DM1 is the best in town for HER2 breast cancer and for its
recurrences. We believe that ImmunoGen’s technology is impressive and so is
the firm’s product pipeline based on its technology. We like the firm and
believe it is way undervalued as traded. | E****e
发帖数: 315 | | E****e
发帖数: 315 | | E****e
发帖数: 315 | 4 from SeekingAlpha
The recent news announcing Genentech’s (DNA) receipt of a “Refuse to File
(RTF)” letter from the FDA for the accelerated approval of the Biologic
License Application (BLA) for trastuzumab-DM1 (T-DM1) has caused a sell-off
in Immunogen, the owner of the technology and partner on the drug with Roche
. According to the FDA letter, the refusal to give the early approval was
because “the trials had not yet exhausted all available drugs approved for
metastatic breast cancer, regardless of HER2 status!
The question is: Is the sell-off a fair market reaction to the news? Our
answer is definitely no. Nothing in the news was related to the drug, its
safety, efficacy, or its breakthrough nature. The FDA did not discuss the
drug’s approvability and has not rejected it. The agency’s letter
constituted a refusal only of an attempt to get the drug early on the market
for the hopeless category of patients with tumor recurrence. Genentech made
this decision based on the results of a single-arm Phase 2 study, which
showed T-DM1 shrank tumors in one-third of women with advanced HER2-positive
breast cancer who had received on average seven prior medicines, including
two HER2-targeted medicines. The results convinced Genentech that TDM-1
works in recurrent HER2 breast cancer that resisted its blockbuster drug
Herceptin and, evidently, the other non-specific treatments.
WOW, said a physician who was hearing the news. She developed HER2 breast
cancer herself and tested positive for BRCA, which means she has inherited
the breast cancer gene. As a matter of fact, her 28 years old daughter
tested also positive for the gene. She has not developed metastasis or any
other tumor recurrence, but she is concerned. Commenting on the FDA letter
explanation to its decision, the physician/patent said, “trying to figure
out what the FDA meant by exhausting all available treatment choices
approved for metastatic breast cancer, the question that keeps crossing my
mind is: Haven’t those patients received prior Herceptin (trastuzumab),
capecitabine, anthracycline, taxane and lapatinib. How much more drugs must
they receive? You know what? The drugs, yes, would be exhausted when
Genentech uses them all, but definitely the patients who would receive them
will be exhausted too. We asked the doctor/patient whether there are
existing data on these drugs that were not used in T-DM1 trials, her answer
was:
Of course the data exist and have been published, yet, why do we need them?
Oncologists know that most non-specific treatments have not helped most HER2
breast cancer even in its early stages, let alone their recurrences. I
wonder why should we withdraw the big hope that HER2 metastatic patients
hanged on since they heard about TDM-1 results – hope that has tremendously
increased since these patients learned about the filing for early approval
of the promising drug. Most these patients might not be around on the
delayed day of the approval.
Herceptin is the first approved HER2 targeted drug. It has improved by far
the bad prognosis of HER2 breast cancer. But the drug has failed to work on
around 50% of the cancer recurrence following a successful initial treatment
. These patients are the candidate forT-DM1, which has demonstrated efficacy
on them.
Trastuzumab-DM1 (T-DM1), in global development by Roche under a
collaboration agreement with ImmunoGen. It onsists of DM1 cell-killing agent
attached to the HER2-binding antibody trastuzumab (Herceptin) using
ImmunoGen’s linker and methods of attachment. The drug is being developed
for all stages of HER2+ metastatic breast cancer (MBC). T-DM1 has
demonstrated the capability of walking the extra step towards killing the
recurrent resistant cancer cells that Herceptin and other drugs failed to
kill. The FDA decision has not affected Genentech’s confidence in the drug
and the firm will continue the EMILIA study, which compares T-DM1 to
lapatinib in combination with capecitabine in people with advanced HER2-
positive breast cancer whose disease has worsened after receiving initial
treatment. ImmunoGen expressed disappointment that there will be a delay in
the opportunity for T-DM1 to be approved for desperate patients and will
continue to focus on the development of its robust and expanding pipeline as
well as advancing its technology through new partnerships.
Currently:
Enrollment is on track in the Phase 3 trial (EMILIA) evaluating T-DM1 for
2nd-line use with 580-patient randomized trial that began in February 2009
and compares T-DM1 – used as a single agent – to lapatinib) plus
capecitabine.
A Phase 3 trial (MARIANNE) for 1st-line trial on route.
Waiting for October to hear the interim data of the phase 2 trial evaluating
T-DM1 for first line treatment. The trial has completed patient enrollment.
The data will be reported at the European Society of Medical Oncology (ESMO
) meeting being held Oct. 8-12, 2010 in Milan, Italy. This trial compares T-
DM1, given as a single agent, to Herceptin (trastuzumab) plus Taxotere (
docetaxel).
Genentech has disclosed upcoming trials to evaluate T-DM1 for early stage
HER2+ breast cancer (adjuvant use) are being considered.
Data from earlier-stage phase 1 and phase 2 clinical trials have been
reported and Information on these and other T-DM1 clinical trials can be
found at ClinicalTrials.gov.
The firm’s pipeline comprises: T-DM1 (see above). Lorvotuzumab, for non-
small-cell-lung cancer, Merkel cell and ovarian cancers, SAR3419, for non-
hogkin’s lymphoma, IMGN 388, for solid tumors. BIIB015, for solid tumors.
BT-062, for multiple myeloma, SAR650984, for lquid tumors, in addition to
other investigational drugs in earlier stages.
Final Note:
We ask those who caused the sell-off in IMGN: Are all these activities and
results worth nothing compared to the refusal to accept earlier approval of
the drug? The FDA has a job to do. We too have a job to do. Let the agency
do its job and let the firms discuss the decision with the agency; it is
their job too. Our job, though, is to assess the value of the firm’s drug
and pipeline.
We believe the T-DM1 is the best in town for HER2 breast cancer and for its
recurrences. We believe that ImmunoGen’s technology is impressive and so is
the firm’s product pipeline based on its technology. We like the firm and
believe it is way undervalued as traded. | E****e
发帖数: 315 | |
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