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Treanda® plus Rituxan® followed by Zevalin® - New Standards for NHL & Indolent Lymphoma

|Includes:BIIB, CEPH, RHHBY, Spectrum Pharmaceuticals, Inc. (SPPI)
ASH 2009
Treanda (bendamustine) plus Rituxan (rituximab) offers new standard of care for NHL and indolent lymphoma

Indolent Lymphoma & AML
  • Treanda plus Rituxan was shown to be better tolerated and improved progression-free survival (NYSE:PFS) compared with standard CHOP plus Rituxan (CHOP-R) as first-line therapy for indolent lymphoma in a multicenter, randomized, controlled trial conducted by the German Study Group on Indolent Lymphoma (StiL).
  • Studies also demonstrate steady progress in elderly patients with acute myeloid leukemia (AML). The results indicate that one cycle of post-remission therapy extended survival in elderly patients with AML.
  • 549 symptomatic patients (splenomegaly, pain, large tumor burden) enrolled at 82 centers, with a median age of 64 years.
  • Patients were randomized to either Treanda plus Rituxan (T/R) or CHOP-R.
  • Of these, 513 patients were evaluable for toxicity and efficacy. 
  • Histologies were distributed equally between T/R and CHOP-R.
     


Improvement in Progression-Free Survival

Source: CancerNetwork

ASH 2008

Landmark Study: first-line consolidation therapy with Zevalin (yttrium-90-ibritumomab tiuxetan)

Indolent Lymphoma
  • 414 patients from 77 medical centers throughout the EU
  • Patients received a variety of induction therapy regimens, which included different chemotherapy agents and, in approximately 15% of patients, also included the monoclonal antibody Rituxan® (rituximab).
  • After induction therapy, patients were randomized to no consolidation therapy or consolidation with a two-course “priming” dose of Rituxan followed by a single dose of Zevalin.
  • The results showed that consolidation therapy – a form of adjuvant therapy after initial or “induction” therapy to induce remission – with a single dose of Zevalin significantly improved progression-free survival in all patient subgroups compared to patients in the control arm, who only received induction therapy.
  • Dr. John Leonard, director of the Center for Lymphoma and Myeloma at Weill Cornell Medical College in New York, its good safety profile and the fact that it is well tolerated by patients makes Zevalin “particularly attractive for [use in] older patients,” who may not handle more toxic chemotherapy regimens very well.

Improvement in Progression-Free Survival (PFS)


77% PR to CR Conversion Rate
  • 77% of the patients, who received a partial response (PR) to induction therapy “converted” to a complete response (NYSE:CR) after receiving Zevalin.
  • According to investigators at the Universitair Medisch Centrum Utrecht in the Netherlands, the team responsible for analyzing the Zevalin study, “[t]his constitutes one of the highest PR-to-CR conversion rates reported in published phase 3 randomized studies in first-line follicular lymphoma.”
Source: NCI Cancer Bulletin, Vol.5 No.21 October 21, 2008.


THE PLAYERS

  • Treanda is marketed by Cephalon (NASDAQ:CEPH).
  • Rituxan is marketed by partners Biogen Idec (NASDAQ:BIIB) and Roche-Genentech (OTCQX:RHHBY). 
  • Zevalin is now marketed by Spectrum Pharmaceuticals (NASDAQ:SPPI).

Q
. Will Treanda affect Zevalin?


Zevalin is already FDA approved for first-line consolidation therapy, which follows induction therapy (combo of Chemo and Rituxan). As I can tell, Treanda would fit into induction therapy and responsible for breaking down the bulky cancer, whereas Zevalin is administered after induction therapy and cleans up the residual cancer. Zevalin converts PRs to CRs and ultimately improves PFS and OS. Generically speaking, Zevalin eliminates the likelihood of recurrence for most patients. So, Zevalin is a cure for most patients.

If anything, the two drugs, Zevalin and Treanda, would most likely be used together in different stages to treat patients with NHL. Example: Treanda would be administered during induction therapy along with Rituxan and consolidation therapy with Zevalin would follow.

Therefore, I view Treanda and Zevalin more as allies in the war as opposed to foes or competitors.


Disclosure: Long SPPI.
Stocks: SPPI, CEPH, BIIB, RHHBY